Our Lady of Lourdes Medical Center is now one of a few select hospitals in the region to offer a new dime-sized pacemaker that is implanted directly in the heart.
Normally, the pacemaker leads are inserted through a vein in the shoulder and placed in the right atrium and right ventricle of the heart. But by placing the leads on an area of the heart called the His-bundle, it can utilize the heart’s natural electrical pathways and create better synchronization between the bottom chambers of the heart.
Listen as Dr. Devender Akula, an electrophysiologist at Lourdes, discusses that through new placement, and new technology, it is an exciting time to be at the forefront of innovation.
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Leadless Pacemaker
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Learn more about Devender Akula, MD
Devender N. Akula, MD
Devender Akula, MD is a clinical cardiac electrophysiology doctor affiliated with Our Lady of Lourdes Medical Center.Learn more about Devender Akula, MD
Transcription:
Leadless Pacemaker
Melanie Cole (Host): Our Lady of Lourdes Medical Center is now one of a few select hospitals in the region to offer a new dime-sized pacemaker that’s implanted directly into the heart. My guest today, is Dr. Devender Akula. He’s an Electrophysiologist at Lourdes Health System. Welcome to the show, Dr. Akula. Let’s talk about the need for a pacemaker before we talk about this pacemaker, to begin with. What kinds of conditions of the heart would require the need for a pacemaker?
Dr. Devender Akula (Guest): Very good morning to everyone. Good morning, Melanie. Thanks for having me. Traditionally, pacemakers have been used in patients who are treated for what we call bradycardia, which means they have a slow heartbeat. The pacemaker prevents the slow heart beat by sending impulses and trying to keep the heart rate at the desired rate for the patients.
Pacemakers have been in use from the 1960s or so, so it’s been a long history with pacemakers. These traditional pacemakers have been implanted by making – it’s a surgical procedure, so you have to make a surgical incision and implant the pacemaker in a pocket in the chest region. That’s called a pulse generator. This pulse generator of the pacemaker has all of the electronics and the battery. This generator is then connected to the heart through wires which are threaded through the vein. These wires we call as leads, and the wires are placed inside the heart. These wires will sense the electrical signals of the heart and also give electrical impulses to the heart to keep the heartbeat going. That’s how a traditional pacemaker had been done for many years.
Melanie: So really, this is just an electrical system that helps to keep the heart going at a certain pace – at a certain speed – help to keep it beating. What is different now? Tell us about this leadless pacemaker. You mentioned to the listeners that the leads were those wires that go into the heart while the pacemaker is in the chest area. What is a leadless pacemaker?
Dr. Akula: A leadless pacemaker is a revolutionized concept in medical or cardiac devices. This pacemaker has no wires. This pacemaker is directly implanted into the heart, and it does not require a surgical procedure. What is done is the pacemaker is threaded through the vein in the groin region using a catheter and inserted directly into the heart – the bottom chamber of the heart, which is the main pumping chamber of the heart called the ventricle. The new pacemaker that is there is about 90% smaller than a traditional pacemaker. The size is like the size of a large vitamin. It’s really a miniaturized device, and its weight is the weight of a penny, so it’s a really small device.
Despite making it a small device, all of the electronics and the battery are within that small capsule and all the traditional functions that the pacemakers do, this leadless pacemaker is able to do also. What is more important and impressive is it is estimated that the battery life of this pacemaker can last up to ten to twelve years depending on how much the patient uses it. It’s a completely non-surgical procedure without any wires attached to it.
Melanie: The battery is an interesting concept because I know with previous pacemakers, they would have to have a battery check, which back in the day, would be done by telephone, really. How do you keep the battery checked? How do you determine that it’s still working?
Dr. Akula: This battery, as I said, is estimated to last ten to twelve years. The battery can be checked in various ways. One is the traditional way when you go and visit your doctor. He’s going to check the device in the office, and that’s one way. The second way – because these devices are wireless, there is a way the patients’ device can be monitored from their home by the doctor using a wireless technology or a wireless module in their home. Believe it or not, the device companies are actually coming up with a phone app that patients can download on their smartphones, which will be the next step as to how these devices will be monitored. The patient can himself know if the battery is still adequate or not by just downloading this app. That will be the next step that the company is coming up with.
Melanie: That is so cool. Is the Micra the right pacemaker for all patients? Are there some people for whom it’s not indicated?
Dr. Akula: Sure, that’s a great question. The Micra does not replace all traditional pacemakers. It is, right now, indicated only for patients who require a single chamber pacemaker or a pacemaker with a single wire in the bottom chamber. It is estimated that about 15% of the patients who need pacemakers are currently candidates for Micra. It’s not indicated for patients who need two wires or three wires, though that technology probably is going to come in the future.
Melanie: Let’s talk about some of the things that people might be concerned about, Dr. Akula. What about things like using a mobile phone, being around magnets, having an MRI? Are any of these things affecting the Micra and what it’s supposed to be doing?
Dr. Akula: The Micra is completely MRI compatible. It’s compatible with the more stronger MRIs that have come out recently. That’s the beauty of this device. It has no interference – at least no known interference with using our day-to-day daily stuff at home like a telephone, or a cell phone, or microwave, TV, refrigerator. It does not interfere with the device, so the patient can literally continue with their normal daily life.
Melanie: Dr. Akula, what are some additional benefits to the patient insofar as cosmetics or comfort, and really, security of this device?
Dr. Akula: Yeah, I think even with the patients – there are a few more things that I think we have to mention. The advantages for the patient – it’s predominantly during the procedure. Because it’s a non-surgical procedure, the patient is up and about with their work much sooner. Because the pacemaker is not sitting in the chest, they can move their hands safely, do what they need to do, don’t worry about swimming or exercise, and things like that, whether that will damage the pacemaker. And cosmetically, you don’t see the pacemaker. It’s invisible, so that’s pretty incredible. You have a pacemaker that you cannot see.
More importantly, the complication rate related to this pacemaker is dramatically lower compared to a traditional pacemaker. What the studies have shown is the complication rate is about 50% lower with this Micra Pacemaker compared to the traditional pacemaker. Because of traditional pacemakers, you have to put the pacemaker in a pocket in the chest. You can get an infection there, so that risk is significantly reduced. You can get bleeding, or you can get a collapse of the lung when they are initially implanting the pacemaker. All of these risks are significantly minimized.
In addition, the leads that connect the pacemaker to the heart, they are the ones that undergo significant wear and tear over a period of time and can fail to function. When these leads fail to function, patients require additional procedures, which can put them at higher risk of complications. All of these complications are not seen with Micra Pacemaker. In the studies that have been done, there has been so far zero dislodgements of this pacemaker, and the infection rate has been almost zero in the study that has been published, which looked at about 700 patients.
There are significant benefits to the patient. The physician -- because the risk and complication rate is lower, it’s good for the physician also, because you’re not doing multiple procedures on the patient. The procedure itself appears to be a much lower risk when you’re trying to implant this device.
Melanie: What would you like listeners to know who might be concerned or who have questions or who are looking for somebody to help them with this? Give us your best advice about bradycardia and heart rhythm issues and why the Micra might be the answer for them.
Dr. Akula: Sure. Right, if they have bradycardia and require a pacemaker, as I said if they need a pacemaker which requires a single wire, Micra is probably the way to go now. This device was initially implanted in 2013. It’s been about four years of experience that’s been there with this device, and the complication risk has been significantly low. One concern the patients have is whether it will get dislodged from the heart and that has not been seen. It’s extremely rare for the pacemaker to get dislodged once it gets implanted because it holds onto the muscle of the heart with the tines that are at the tip of the pacemaker. I think the final decision will have to be made after consultation with their cardiologist and their electrophysiologist because not all patients would be candidates for this leadless pacemaker.
Melanie: Thank you, so much, Dr. Akula, for being with us. What a fascinating topic. You’re listening to Lourdes Health Talk, and for more information, you can go to LourdesNet.org, that’s LourdesNet.org. This is Melanie Cole. Thanks, so much for listening.
Leadless Pacemaker
Melanie Cole (Host): Our Lady of Lourdes Medical Center is now one of a few select hospitals in the region to offer a new dime-sized pacemaker that’s implanted directly into the heart. My guest today, is Dr. Devender Akula. He’s an Electrophysiologist at Lourdes Health System. Welcome to the show, Dr. Akula. Let’s talk about the need for a pacemaker before we talk about this pacemaker, to begin with. What kinds of conditions of the heart would require the need for a pacemaker?
Dr. Devender Akula (Guest): Very good morning to everyone. Good morning, Melanie. Thanks for having me. Traditionally, pacemakers have been used in patients who are treated for what we call bradycardia, which means they have a slow heartbeat. The pacemaker prevents the slow heart beat by sending impulses and trying to keep the heart rate at the desired rate for the patients.
Pacemakers have been in use from the 1960s or so, so it’s been a long history with pacemakers. These traditional pacemakers have been implanted by making – it’s a surgical procedure, so you have to make a surgical incision and implant the pacemaker in a pocket in the chest region. That’s called a pulse generator. This pulse generator of the pacemaker has all of the electronics and the battery. This generator is then connected to the heart through wires which are threaded through the vein. These wires we call as leads, and the wires are placed inside the heart. These wires will sense the electrical signals of the heart and also give electrical impulses to the heart to keep the heartbeat going. That’s how a traditional pacemaker had been done for many years.
Melanie: So really, this is just an electrical system that helps to keep the heart going at a certain pace – at a certain speed – help to keep it beating. What is different now? Tell us about this leadless pacemaker. You mentioned to the listeners that the leads were those wires that go into the heart while the pacemaker is in the chest area. What is a leadless pacemaker?
Dr. Akula: A leadless pacemaker is a revolutionized concept in medical or cardiac devices. This pacemaker has no wires. This pacemaker is directly implanted into the heart, and it does not require a surgical procedure. What is done is the pacemaker is threaded through the vein in the groin region using a catheter and inserted directly into the heart – the bottom chamber of the heart, which is the main pumping chamber of the heart called the ventricle. The new pacemaker that is there is about 90% smaller than a traditional pacemaker. The size is like the size of a large vitamin. It’s really a miniaturized device, and its weight is the weight of a penny, so it’s a really small device.
Despite making it a small device, all of the electronics and the battery are within that small capsule and all the traditional functions that the pacemakers do, this leadless pacemaker is able to do also. What is more important and impressive is it is estimated that the battery life of this pacemaker can last up to ten to twelve years depending on how much the patient uses it. It’s a completely non-surgical procedure without any wires attached to it.
Melanie: The battery is an interesting concept because I know with previous pacemakers, they would have to have a battery check, which back in the day, would be done by telephone, really. How do you keep the battery checked? How do you determine that it’s still working?
Dr. Akula: This battery, as I said, is estimated to last ten to twelve years. The battery can be checked in various ways. One is the traditional way when you go and visit your doctor. He’s going to check the device in the office, and that’s one way. The second way – because these devices are wireless, there is a way the patients’ device can be monitored from their home by the doctor using a wireless technology or a wireless module in their home. Believe it or not, the device companies are actually coming up with a phone app that patients can download on their smartphones, which will be the next step as to how these devices will be monitored. The patient can himself know if the battery is still adequate or not by just downloading this app. That will be the next step that the company is coming up with.
Melanie: That is so cool. Is the Micra the right pacemaker for all patients? Are there some people for whom it’s not indicated?
Dr. Akula: Sure, that’s a great question. The Micra does not replace all traditional pacemakers. It is, right now, indicated only for patients who require a single chamber pacemaker or a pacemaker with a single wire in the bottom chamber. It is estimated that about 15% of the patients who need pacemakers are currently candidates for Micra. It’s not indicated for patients who need two wires or three wires, though that technology probably is going to come in the future.
Melanie: Let’s talk about some of the things that people might be concerned about, Dr. Akula. What about things like using a mobile phone, being around magnets, having an MRI? Are any of these things affecting the Micra and what it’s supposed to be doing?
Dr. Akula: The Micra is completely MRI compatible. It’s compatible with the more stronger MRIs that have come out recently. That’s the beauty of this device. It has no interference – at least no known interference with using our day-to-day daily stuff at home like a telephone, or a cell phone, or microwave, TV, refrigerator. It does not interfere with the device, so the patient can literally continue with their normal daily life.
Melanie: Dr. Akula, what are some additional benefits to the patient insofar as cosmetics or comfort, and really, security of this device?
Dr. Akula: Yeah, I think even with the patients – there are a few more things that I think we have to mention. The advantages for the patient – it’s predominantly during the procedure. Because it’s a non-surgical procedure, the patient is up and about with their work much sooner. Because the pacemaker is not sitting in the chest, they can move their hands safely, do what they need to do, don’t worry about swimming or exercise, and things like that, whether that will damage the pacemaker. And cosmetically, you don’t see the pacemaker. It’s invisible, so that’s pretty incredible. You have a pacemaker that you cannot see.
More importantly, the complication rate related to this pacemaker is dramatically lower compared to a traditional pacemaker. What the studies have shown is the complication rate is about 50% lower with this Micra Pacemaker compared to the traditional pacemaker. Because of traditional pacemakers, you have to put the pacemaker in a pocket in the chest. You can get an infection there, so that risk is significantly reduced. You can get bleeding, or you can get a collapse of the lung when they are initially implanting the pacemaker. All of these risks are significantly minimized.
In addition, the leads that connect the pacemaker to the heart, they are the ones that undergo significant wear and tear over a period of time and can fail to function. When these leads fail to function, patients require additional procedures, which can put them at higher risk of complications. All of these complications are not seen with Micra Pacemaker. In the studies that have been done, there has been so far zero dislodgements of this pacemaker, and the infection rate has been almost zero in the study that has been published, which looked at about 700 patients.
There are significant benefits to the patient. The physician -- because the risk and complication rate is lower, it’s good for the physician also, because you’re not doing multiple procedures on the patient. The procedure itself appears to be a much lower risk when you’re trying to implant this device.
Melanie: What would you like listeners to know who might be concerned or who have questions or who are looking for somebody to help them with this? Give us your best advice about bradycardia and heart rhythm issues and why the Micra might be the answer for them.
Dr. Akula: Sure. Right, if they have bradycardia and require a pacemaker, as I said if they need a pacemaker which requires a single wire, Micra is probably the way to go now. This device was initially implanted in 2013. It’s been about four years of experience that’s been there with this device, and the complication risk has been significantly low. One concern the patients have is whether it will get dislodged from the heart and that has not been seen. It’s extremely rare for the pacemaker to get dislodged once it gets implanted because it holds onto the muscle of the heart with the tines that are at the tip of the pacemaker. I think the final decision will have to be made after consultation with their cardiologist and their electrophysiologist because not all patients would be candidates for this leadless pacemaker.
Melanie: Thank you, so much, Dr. Akula, for being with us. What a fascinating topic. You’re listening to Lourdes Health Talk, and for more information, you can go to LourdesNet.org, that’s LourdesNet.org. This is Melanie Cole. Thanks, so much for listening.