Who would be the target patient for this device and why?
Dr. Andrew Kaplan: Millions of patients in the United State have coronary artery disease. Many of these people have already suffered a myocardial infarction or a heart attack or have had some other acute event which has led to an intervention such as angioplasty or stenting. We know that all of these people are at significant risk for having recurrent events, that being either a threatened heart attack or a full heart attack.
Is part of the issue too for these people, that it can happen so suddenly and tell me a little about that and sort of the danger of that, and then get into the importance getting them to the hospital quickly and being aware that something is going on.
Dr. Andrew Kaplan: Well there are several problems involved. We know first of all that people who have heart attacks may have symptoms that are not necessarily typical and may vary from one event to the next. Whereas they may have chest discomfort one time, they may not have that the next time that they have an event. We also know that heart muscle loss is dependent upon time blood flow is cut off, and the earlier you can intervene, the less likely you are to lose a significant amount of heart muscle in the setting of a heart attack. We also know that people will tend to try to minimize their symptoms, or may confuse their symptoms from GI sources or musculoskeletal sources with coronary disease. What we would like to avoid for these patients is that every time they have any sort of discomfort, they feel that they immediately run to call their doctor or run to the emergency room.
So what is this device that's in clinical trial, what is it and what does it do?
Dr. Andrew Kaplan: The AngelMed Guardian Device is what we call an ST Segment Monitor. It is a fully self contained implantable system with a device going underneath the skin and a wire going into the heart just like a pacemaker lead. The device is structured very similarily to a pacemaker but, whereas a pacemaker is used to actually stimulate the heartbeat, this is looking for subtle changes that are associated with a decrease of blood flow to a region of the heart.
So tell me and if you could start by saying if it notices something what it would notice and what would happen if it noticed that thing?
Dr. Andrew Kaplan: When there's a decrease in blood flow to the heart you get a change in the surface ECG in what's called the ST segment. That can be either a decline or an increase in that ST segment beyond base line. The specific lead which changes reflects the change of blood flow to a specific region. What this device is looking for are changes in the ST Segment which could then indicate that something is going wrong in the heart.
And then what happens?
Dr. Andrew Kaplan: When this occurs two things will happen. One is that the device has the capability of vibrating so that the patient can actually feel an alarm telling him that something is wrong; the second is that the device has an antenna to transmit a signal to an external monitor and that will then cause a light to flash and an alarm sound to occur and let the patient know again that there is something going on with their heart. There are two different types of alarm systems set up for the device: one of these is a reminder to go to the doctor at the next available opportunity because they may have had a short term event and the other is an emergency alarm letting them know they need to call 911 and get to the hospital right away.
What's the beauty of a device like this with the patients you see?
Dr. Andrew Kaplan: It allows patients to have a constant monitor with them at all times. You know the doctor isn't always going to be able to be there to do an EKG whenever you're having some problem. If you're at work, with your family, or sleeping and something happens and you don't know what to do, this provides that reassurance to you that either everything is okay or something is wrong and you need to seek help.
How big a deal is that with these patients, you talk to these people, are they scared that once they've had one-they're scared, they're nervous, they're worried especially that they're older folks very often
Dr. Andrew Kaplan: Absolutely, in both older and younger people. I've been very surprised over the years at how many younger people are now presenting with coronary artery disease, unfortunately, in their 30's and 40's. All of these people may become psychological cripples, paralyzed by fear about their disease, They don't know what to do and, as a result of that, any time they have some sort of discomfort they will either try to minimize it because they don't want to have to go through an event again, or they run to the emergency room and end up using up valuable resources when nothing is wrong. So I think this would give them enormous peace of mind.
And how is this device implanted, how do you put it in the chest and where does it go?
Dr. Andrew Kaplan: It's implanted just like a pacemaker underneath the skin in the chest area. The device is inserted in a procedure under local anesthesia with mild sedation in a cardiac catheterzation laboratory . We apply little bit of local anesthesia on the chest and make an incision about 1 ½" long, make a little space underneath the skin where the device will sit, and then introduce the pacing lead into the subclavian vein which is the vein running underneath the collarbone. We then use an X-ray camera to position it in the right ventricle.background interferenceokay
So I'm just going to ask you tell me again where you put it in (and you don't have to be very specific) where the wire goes and that kind of thing
Dr. Andrew Kaplan: The device is implanted very much like a pacemaker so that the generator itself sits underneath the skin in the chest area and then there's a wire lead inside the body going into the vein under the collarbone down into the heart.
How big of a breakthrough do you think this is to have a device that can effectively watch these people and give them an alert of something that could be very dangerous to them?
Dr. Andrew Kaplan: This is really revolutionary technology. This sort of ST Segment monitoring has been used in the intensive care unit after interventions to look at people who have had heart attacks and who may be threatening to have another one. This is the opportunity for people to always have that as the device is named guardian with them at all times to watch and provide every assurance for them.
END OF INTERVIEW
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