Dr. John D. Rogers outlines recent advances in cardiac device therapy including new options and technology developed to optimize device connectivity and remote patient monitoring.
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Alright, we're gonna move on to dr Rogers, who's going to give us an update on implantable cardiac devices for for therapy as well as for monitoring Dr Rogers is been at Scripps Clinic since before I got there, in fact, trained me back in the good old days. Um He's now the medical director of the implantable devices program at at scripts. And there's also the medical director for the Medtronic Link monitoring program nationally. So he's a very good source to get an update on what's happening in the implantable devices arena. Thanks for joining us. I'm really glad to be here and to be able to wrap up our conference this weekend. Um As the last speaker, I'm going to be talking about recent advances in cardiac monitoring pacing and therapies. And I'm really going to focus on the more recent advances, meaning more recent than perhaps when you were here at this conference and years passed last year or two past. Some of these advances are brand new summer within the last year or two. Um here's my disclosures. So what are the recent advances in cardiac monitoring pacing And I see the therapies? Well, it's interesting. Uh there's advances in options and technology for direct to consumer monitors. They're all there's a new company seems to be popping up every day and a new advancements in what patients can order online or at amazon themselves for cardiac monitoring. And we'll mention that little briefly, there's enhancements to optimize connectivity and remote monitoring with bluetooth technology more and more being enabled in implantable devices. And what's really interesting is we've known for a long time how important accurate and close remote monitoring needed to be even before the pandemic kind of shut everything down and doctors and other health care professionals who never thought of going into telemedicine, we're all forced to and with that these devices seem to be primed these new technologies that optimize connectivity via bluetooth and optimized our ability to more accurately and completely remotely monitor our patients. Um We're seeing an increased number of physiologic parameters that can be measured by these devices. Were seeing longer battery life's. We're seeing smarter devices algorithms to help us program devices to help our patients to make sure they're CRT responders. But that's what I mean by devices getting smarter. We've seen enhancements to some pacing leads one in particular that I'll talk about. We've seen a new class of pacemaker. We've been dealing with leaderless pacemakers and implanting them for a number of years. But now more recently we have what we'll call a dual chamber atrial sensing, ventricular pacing, leaderless pacemaker. And I'll talk about that. And we just recently earlier, just heard dr Donda moody talk about physiologic pacing. So patients are just now wondering, okay, I have this latest greatest state of the art pacemaker, what else? What can it do for me? So I thought that this cartoon was pretty um perfect for this. You can download other apps for your other organs. So eventually maybe one day that will happen. So today's discussion is going to focus on external cardiac monitoring. Either direct to consumer or prescribed monitoring that we use implantable cardiac monitors, pacemakers. And I see the CRT therapy. So for a long time for the direct to consumer, we've had the smartphone apps where we can place our fingers on a recording electrode and come up with a single lead rhythm strip here in the last year. So we now have the ability to have that same little double electrode recording device with another recording pad or electrode on the backside. And so if you order this from amazon and you use this monitor and you place it on your skin of your leg, wear shorts or what have you. With your two fingers on top. It's touching three different points of contact That gives us a six lead E. K. G. So not just a single rhythm strip anymore but a 63 D. C. G. We have smart rings that have developed or a ring as a company. But basically this is a ring and it comes in gold, silver, platinum and black. Ah nick. They refer to it and look at the sensors inside this ring and they're not there. This ring is positioned to magnify and show the electronics. But patients that I have that where these it just looks like a ring. I've even had one married couple have it as their wedding rings. But these monitor these through the patient's smartphone are able to monitor physiologic parameters, temperature, oxygen, saturation, heart rate, variability, heart rate in general sleep parameters. These can even tell patients what level of sleep that they're in and how well their sleep has been going, calories burned activities. So smarter and smarter technologies into everyday things that we would wear a ring or a watch. We all know about the Apple watch. It's been around forever if I'm working a long day and I want to snack, I'll wear my Apple watch as you can see there. But basically the Apple watch was one of the first forays into being able to tell us our heart rate and then to record a rhythm strip. And this has been very well marketed looking for atrial fibrillation. These things these devices, watches, rings, other things have their limitations but they're also very helpful. And patients will come in with printouts with atrial fibrillation from their watch or other monitors. Sometimes they'll come in with pronounce of atrial fibrillation, it's not atrial fibrillation and that consult usually is is a little easier as far as trying to reassure patients, not even had patients say they don't believe me, they believe their Apple watch. So go figure there's everybody in between. But we're also seeing the Apple. Apple is a corporation doing more with this watch. We're seeing other companies doing more with their watches company out of Israel has a watch that will be released this coming year that has the ability to tell us our time, believe it or not to watch, telling time. Kind of an interesting concept but heart rate rhythm 02 saturation blood pressure, all types of different physiologic parameters. So we're seeing more and more of these devices come out on the market for patients to be able to acquire without a prescription. And a lot of physicians are using these devices as screening tools for those patients. Maybe they don't think are at higher risk. I have palpitations. They last for a few seconds or minutes. They're very sporadic. Sure we can use an external monitor depending on the frequency of their symptoms. Yes we can also use an implantable cardiac monitor depending on the frequency of their symptoms. But more and more physicians are using these directed consumer devices as well and they're getting smarter. Recent advances are making them smarter if we look at the prescribed E. C. G monitoring tools well we have event recorders, Holter monitors, extended holter monitors, mobile cardiac telemetry and now all four pacemaker device companies making an implantable cardiac monitor. And incidentally this is not a endorsement of any company is just to show that all four pacemaker companies now have one of these monitors. The more recent advances in the prescribed external monitoring patches or lead ID systems. Well again it was happening before the pandemic. But with the pandemic it really magnified how important these features are, including home enrollment. If we're seeing a patient via telemedicine and we think they need to wear an external monitor, we can order that through our electronic record and specify a home enrollment. So the patient hasn't come in. The patient doesn't have to come in for the monitor. It can be sent home to them. We know that there's more compliance patients will wear the monitor for most of the prescribed time if it's less cumbersome. So more and more companies are going to patch based technology instead of wires and electrodes. A lot of the companies that then monitor this information that they're independent diagnostic testing facilities or I. D. T. S. Where there's technicians gathering this information, correlate collating it and then getting it to us. Either be alerts or reports are leveraging artificial or augmented intelligence to help in the volume of information that's coming in. That then comes to us as the physicians and other professionals taking care of these patients. And there's more and more flexibility that's developed with these companies to allow us to access that data so we can we can access a secure website and see what our patients have had coming in. We can even do that through an app with some of the companies. So it's made our accessibility to see what our patients are having on their monitors a lot easier and more complete as far as the implantable cardiac monitors. Well there's now four of these. Two of these, One has been around this size since 2014. Uh, it's new generation has come out within the last year. Another one has come out the boston scientific lux has come out this past year. But how these devices are evolving and advancing include bluetooth enabled technology to allow a more rapid download of the information instead of one that may take all night long. Two of the devices now offer remote program ability so the patients don't have to come back in for us to change any programming. All of the companies are heading that way. Their improved algorithms are more accurate at determining atrial fibrillation and pauses. There's different algorithm enhancements that have been developed and evolved in these devices to make them more accurate and to decrease the amount of false positive information, meaning the device thought there was a fib but it's not, it's sinus rhythm with a lot of premature beats. The algorithm enhancements are getting rid of that information before it even becomes a burden to our clinics. They're now able to, one of the devices is now able to record PVC burden which is useful for a lot of electro physiologists and cardiologist who are trying to decide do I treat that? Should they have an ablation? Should we use pharmacologic therapy devices range from 2.5 to 4.5 years but the trend is for them to increase in time so that we can monitor a fib which is a lifelong disease. And with the newer sensors coming other sensors for monitoring heart failure and other types of things. These are lifelong conditions that we want. The device is lasting longer to help us to be able to follow them. So smarter longer lasting, more enhanced algorithms for more accuracy and better remote follow up and connectivity are really what we're seeing in these types of devices. What about pacemakers? So if you think about the history of pacemakers, Albert Hainan created the first artificial pacemaker in the late 50s. It was a crank type device and kept people alive as long as it was being cranked. Then we developed in the late fifties, a c powered pacemaker units attached to an extension cord. And I've actually seen a video of this gentleman pushing around his cart with his big electronic boxes with the power cord plugged into the wall. This is from the 19 fifties and if the power went out, sorry, that was, that's all, that's all she wrote for that for that individual. But it still was the advance in technology Earl back in and see Walton little high who? Earl back. Unfounded. Medtronic created a battery powered external pacemaker And I was ruined. Elmquist and a Christening from Sweden who created the first fully implantable cardiac pacemaker about the early 60s. So for the last 60 years we've had an implantable pacemaker. We've had leads. There's been enhancements in battery longevity, there's been enhancements and being able to remotely monitor. There's been enhancements in the lead since epic cardio leads back then and now trans venus leads. But in general, that's what it's been for the last 60 years. A generator and a lead. So what's more recently been the advancements and pacemakers? Again, again, a traditional pacemaker. And you can see the leaderless pacemaker and compare that to a size of a vitamin. You can see this new class of pacemaker that developed. But in pacemakers, the recent developments are their Bluetooth enabled, which allows faster, more reliable communication. The patient can use their own smartphone via an app. They no longer have to have a bedside monitor and take that bedside monitor. If they travel, we have a fair amount of mobile patients. They'll say, well I'm gonna go to my home in Illinois for the summer months and I'm back here for the winter months. So I'm going to go travel through europe for a few months and then it's really on it's really a problem for them to carry their bedside monitor if they have a smartphone and as long as their cellphone service where they're at via the app, they are in wifi, they can access and let us be able to access their device as far as communication. Um There's this is allowed enhanced remote monitoring to be able to monitor patients which became we know has been improved mortality and morbidity much less. Again, being able to stay connected with our patients and the leaderless pacemaker. The this one is showing what's the only one available now called? The Micra is showing that the first lead this pacemaker that when it came out was only a single chamber of E. V. I. Pacemaker. But now with the microwave E. We have the ability to sense the atrium pace the ventricles. So think about. Usually this would be a pacemaker predominantly that would be used in atrial fibrillation patients that don't require an atrial lead. But now we can use the microwave. E. This a sensing v pacing lead this pacemaker and patients with heart block because as long as the sinus rhythm is intact, then we can sense the atrium paste the ventricle and the next near future advance will probably see true. Dual chamber device is one of the other companies. Abbott is actually looking at that and having physicians do some some animal work and and could ever work to see. So this is a new pacemaker class has come out in the last few years. The A. V pacing has come out really in the last year. The A sense V pace. So that's really what these advances are in pacemakers. So why a leaderless pacemaker? It actually meets some clinical unmet clinical needs in cardiac pacing. Um, there's no chest scar, there is no visible bump of the pacemaker, there's no visible or physical reminder of a pacemaker under the skin. There's fewer post implant activity restrictions. Um, there's eliminated pocket related complications such as infection, hematoma, erosion, less lead complications, such as fractures, installation breaks, noise on the leads, venus, thrombosis or obstruction requiring intervention. And let's try, let's try custard regurgitation. One in eight patients treated with the traditional pacing system will experience a complication attributed to the pockets or leads. That's pretty significant. And of course leading pocket related complications can be devastating to a patient and costly to a patient in the hospital. So what are some of those complications? Well with having to use a needle to access the left axillary vein or subclavian vein we can see pneumothorax. It may be hard to appreciate that the yellow arrows are outlining the lung has collapsed here. So in this implantation which otherwise was successful there's a pneumothorax, we can see a hematoma develop. Especially there's a lot of our patients are on anti platelet and anti coagulation drugs and they may not be able to stop those safely if they've had a stroke. I think bridging them with heparin. Lovenox actually enhances the bleeding so I usually don't stop anti coagulation. So the hematoma is one complication. Unfortunately most of these resolve. However, there can this can be a new milieu for bacteria to set up infection and we worry about between infection that's smoldering or indolent and or thinning of the subcutaneous tissue of a lead being exposed or extruding through the pocket. Um No amount of antibiotics will cure that. That's a problem where once that have skin um integrity has broken, Pool's open and the bacteria just dive in. So that's requiring a removal or replacement removal. Excuse me in treatment and to go to the other side for the device. Uh This is a chest X ray that shows a zoomed in version to show another complication of leads and that's the lead fracturing on the installation, usually in that clavicle, rib, first rib junction. Again another problem with leads requiring extraction and or more leads to be placed. And of course more modern problems such as a patient deciding to get a tattoo right over there, pacemaker incision and the reds sort of irritation of the skin that's normal. After a tattoo in this person's case turned into cellulitis which went deeper and infected their device. So one of the big recommendations is for people, especially if I see they have a number of tattoos already, not a judgment or a bias. Just to say for the love of God, do not get a tattoo over your incision. And so that is a conversation we have to have. So the leaderless pacemaker, it's about 93 smaller than traditional pacemakers. You can see over here on the left of your screen. Radiographic image, freezing, showing the insertion and deployment. There's a delivery catheter that has a marker band on the end and you can see uh that the introducer comes right up into the atrium. The delivery catheter comes up in across the valve and against the R. V. A. Pickle septum we can see a marker band at the end of the catheter and the leaderless pacemaker is here inside the catheter. The next image in the middle is more of a demonstrating um type of slide to show. This is with the lead, this pacemaker with these little Knighton hall which is a flexible metal times that are inside the catheter. Once the catheter is pulled back and the leave this pacemaker starts to deploy. These times grab into the heart muscle and come back on themselves. Um It's really a one step process. Not a lot of multiple steps. And then we d attach the leaderless pacemaker. So here you can see where the leaderless pacemaker would be sitting. There is no leads to go across the tri custom valve or in the vein and no incision up under the collarbone. This is delivered from the femoral femoral vein. So what are the recent advances in I. C. D. And C. R. T. Um therapy? Well again, the Bluetooth enabling is really a big deal at the low energy. Bluetooth allows us to uh not to allows for longer battery life, most likely. Most importantly enhanced remote monitoring capabilities which we've already discussed, especially in I. C. D. And C. R. T. We want to know more than just the every 3 to 6 month visit. Are they buy be pacing 100 of the time? Are they RV pacing too much of the time if they don't have a CRT, how much atrial fibrillation are they having? Is there any issues that's popped up with the leads that we need to know about noise on the leads or or or other things that make us concerned about the leads that are alerts that are programmed. But having the ability to better remotely monitor these patients makes it safer. As I said, that's been proven there's less morbidity and mortality by remotely monitoring our patients. Well, again, we're seeing better battery longevity. That golden target of hopefully 10 years or more. Again, depending on how much the devices pacing, depending on how high the thresholds are, depending on how many times it shocks the patient. If it's an ICD that will all play into how long the battery lasts, the devices have had so many features added here in the last number of years that all those things take batteries. So we have to yes, we want the best smartest device but we have to also realize that could use a fair amount of battery and I'll show you what I mean by all these features here in just a minute, The technicians that each of these companies and the people who write the software algorithms have developed smart algorithms that we can use that device programming at implant and beyond to ensure by the pacing, right. If we're not by the pacing 98 or more, our patients are not going to do as well. But algorithms exist to hopefully optimize Bybee pacing with that. A V synchrony and VV synchrony as well algorithms, smart algorithms to help prevent inappropriate shocks are also what exists in in almost all of these devices. There's new sensors and alerts for monitoring heart failure that we can hopefully be triggering an alert to alert us before a patient may even realize, hey, I'm getting more short of breath and having more oedema. So again, being able to use these devices for treating other disease states like atrial fibrillation and heart failure. And then again, one of the more recent advances in leeds is that the there there is an active fixation LV lead, which I'm going to talk about in just a moment. So what is CRT therapy? Well, CRT therapy is where we have a device that's going to pace both sides both ventricles to try to eliminate the VDV. Dissing pretty. That occurs that can weaken our heart over time. We heard that with DR donna movies presentation. So usually it involves if there's not persistent or chronic atrial fibrillation, a right atrial lead, right ventricular lead. And then the lead that goes out into the coronary. Scientists, usually on the left lateral wall of the ventricle to to offer pacing from the left ventricle and realize that usually when we put a lead in the atrium or the ventricle, there's an active fixation helix that holds onto that muscle so the lead doesn't move with the movement of the heart. But the coronary sinus and cardiac vein pacing leads have not had an active fixation helix. They've had the initial leads were straight and there was a higher rate of dislodge mint or pulling back in the vein. Um leads then developed specific type curves which I'll talk about and show in a minute. But we're going to talk about the newest sort of lead iteration which is an active fixation lead to go in the coronary scientist. But if we look at the C. R. T. Devices themselves we can look across the board at all four companies. And again this slide shows you that in some things are all very much alike. They all have uh remote monitoring. They all have alerts to alert us to problems that we can program what those alerts should be. We all they have anti attack, a cardio pacing, they record episodes of arrhythmia. There's some form of atrial fibrillation, either overdrive pacing or suppression. There's algorithms here in the second to the top road to decrease inappropriate shocks. And there's automated algorithms to help us to know what's the best way to program our device. So these are all the basics of CRT devices that all companies have. If we look about the last couple of years, as far as different things, we can see that there are differences. Whereas the most recent devices are the last two on the right here and the Abbot gallant device. And as you can see, they all have a lot of the similar features. But more more recently we're seeing more and more features be added to these devices. So for example, the orange boxes showing the heart failure alerts. So we we some companies offer heart failure alerts and I'll talk about that here in just a minute again. But as we and bluetooth you can see this yellowish colored box showing that most people have the are developing the Bluetooth technology. But keep in mind that although some have more features turning on those features and making sure that they're all maximized may impact battery life to some degree. So whereas we have um the probably the device with the longest battery life would be the boston scientific device. They may not have as many features but they have a lot of the same features that everybody else has. But again, more features that cause the device to think more and do more may use battery life. So we have to balance those new features with that. So we don't want our patient necessarily coming in if they have high thresholds and they're using the defibrillator a fair amount In five or six years. We want to push them to hopefully get them out to 10 years unless there's some feature that they may require more than another company may have. So sometimes we pick the device for the features for each specific patients. Sometimes we especially older folks may want to say we don't want this person to have to come back for a generator change in their lifetime. If possible, all those decisions may go into picking which device we use If we look at the time, course of heart failure decompensation and what a device mayor may not be able to do for us. So this was the first company that came in with the ability to monitor and help us with heart failure alerts. So if we look at the timeline here, usually 30 days before a patient starts to have symptoms, there may be decreased cardiac output. We may say, increased left atrial pressure. The sympathetic nervous system is energized or more active pulmonary fluid may start to increase without the patient even having symptoms necessarily. Yet We may see their weight go up by about 10 days and we may see them develop symptoms 30 days after this process or cascade starts. So if we look at what those changes, physiologic changes may relate to, we may see a change in the heart sounds. The S three may become louder, the neuro hormonal response and the heart rhythm variability may change thoracic impedance may change respiratory rate may increase, and how we sleep on flat or pillows may change. Our weight will increase in our activity will decrease. Well, how can a device help us here? And you can see that one of the companies and other companies are trying to start doing those things. Come came up with this heart failure index and so by using heart sounds or the S. three intensity, the thoracic impedance measurement which everybody has as far as the devices respiratory rate activity level, which most have and heart rate variability and develop a composite daily score. The heart failure, the heart logic, heart failure index score. And we can program, okay, when the score gets above a certain level, alert me, alert me to tell me that this patient scores high and they may be going into heart failure again. Using the device, we've had the thoracic impedance measurements for many years. But using this suite of heart failure sensing parameters, we can be alerted hey, our patient may be getting into trouble as far as heart failure and call them. talk to them. Hopefully get them in and get them maybe diarist or treated or referred to our heart failure specialists before they get into trouble and need to be put in the hospital. So these parameters can emulate clinical assessments. Again, there's multiple sensors, not just one. These are objective measurements related to heart failure. Um and we can, we can personalize this to the patient as far as when we set that alert to let us know. Um it was developed and validated 900 patients since this that it's been out in practice now for a number of years. Um and heart failure doctors are finding it fairly useful when I talk about the bluetooth connectivity that a lot of the companies have. I really can't understate that because imagine instead of a bedside monitor where patients just sees a green light or doesn't know if there's any information going through the patients can use their own smartphone to automatically transfer device data via the mobile app. And so even when there traveling and wherever in the world necessarily, they can be connected if their cell cellular wifi service there, so we can see the patient can see their battery longevity there, implant, date, the device name and serial number. Um, they can track their own vital signs, their own physical activity. They have connection to our clinic as far as information. Very important that connectivity status patients always wondering, you put this in, You tell me I'm connected. Am I? This helps tell the patient real time. Are they connected? Uh My transmissions. Has the patient's transmission been sent when it's supposed to every three months or whatever the interval is. Did they get it? This will tell them. Yes, your transmission was received. Patients can create a journal of symptoms and also there's educational information there so that our patients the number of questions they would normally ask. We can have them go here for educational materials. And this is something that really one of the companies has now, the others are coming out with and they're all working to develop it. Yeah, it's really important because if you think about the patients from the patient's aspect of being monitored, it lets them know. I think that they're being monitored much better. Um in the sense of they can go wherever they want with their cell phone obviously and that's their monitored relating or connecting to us. But also it also helps our device clinic. Right? So if a patient is on on a bluetooth on their cell phone type of monitoring for remote monitoring, 40 of the device clinic call burden is due to patient calls surrounding really four main issues and it's for recurring issues. Did the transmission go through that their devices sent and this will tell them. Yes. Your transmission was successful is received on the following date. Am I connected? Yes, real time tells them. Are they connected at any time? Are they disconnected? Otherwise? Patients may not know if their bedside monitors not communicating to us, but this tells patients not to disconnect but it reminds them if you do disconnect reconnect and a lot of patient education or calls to ask questions about their device, all that information. Most of that information is right here. They can just access on their own phone at any time. Yes. So what's new about this lead I was mentioning? So there's there hasn't been a lot of change here recently in the right atrial leads or the right ventricular pacing leads or the right ventricular I. C. D. Leads. But there has been a new update here in the coronary sinus cardiac vein pacing leads. So if you remember I mentioned that the leads had, they were straight initially and these straight leads had a higher incidence of dislodging. So the companies added these curves to help them a straighten out with a wire. But when we remove the wire from the lead which is placed over the wire into the vein, the lead attains its shape. And so what the companies now have similar shapes to make sure that they work with physicians who like a certain shape. But the first quadra polar lead quadra polar meeting four electrodes 1234 And you can see them on these leads to offer more pacing options. The first was the S. Curve and then the canted was stereotypical for one of the companies and then the spiral very stereotypical for one of the other companies. But all the companies have these quadra polar leads and these leads, unlike the right atrium and right ventricular early went out into the vein but only the curve was providing some pressure against the vein wall to keep the lead from dislodging or pulling back. Um It's helpful but you can easily pull back the lead and the movement of the heart may cause the lead to move if it's a big vein, if it's a very big vein that the leads in the lead could move inside that vein. So um and that is a cause of having to go back in and redo surgeries. It's a cause of having to not have adequate CRT or by ventricular pacing. So the development was too, and this is a quadruple or lead how it looks on X ray. Um Here 1234 electrodes um in the heart. But the development was to add an active fixation helix or the little um screw mechanism to to actually attach the lead so it doesn't pull back. And so the basically this little helix and it's here you can see it blown up in the square that's blown up there, it's a helix that's between the 3rd and 4th electrode. If you count electrodes from the tip 1234 This helix is there between the 3rd and 4th electrode and it's meant to basically being able to rotate that lead and screw that lead into the side wall of the vein. Um And so um The lead is approved for 1.5 and three. Tesla MRI does allow for multi point pacing. Which is one of the features that devices now have. Um So uh let's talk a little bit about the safety of this and how, why it's helpful. So when we had a quadra polar lead we could place that lead out into the vein. And you can see the four electrodes here on this lead in an outside diagram attic, hashed silhouette of the heart. This is in an R. E. O. View. And sometimes in order to get, you know, to make sure the lead was stable in a vein, we'd have to put the lead way out in the vein. We know from made at CRT one of the large trials that if we pace from the a pickle section of the L. V. We can actually increase morbidity and mortality. So, ideally we're trying to make sure we're pacing from the basil or mid part of the left ventricle. And you can see here that only one of the electrodes is really in the mid part of the left ventricle. Yet if we were to pull this lead back to be in the basil the midsection, well the vein is a lot bigger there and it's possible that that vein that lead could pull out of the vein if we do that. But if we have the active fixation mechanism onto that lead, we can put that lead and you can see here on the right side of your screen anywhere we want to in that vein and and rotate and turn the lead given enough turns that that helix will screw into the side of the vein and keep it more actively fixated there. So we can be more selective at where we put these LV leads. Um to be able to help patients. And so the the active fixation helix reduces the risk of Of lead dislodged and here's a video to show this happening. The lead is being torqued and the helix is at 12:00 now it's gonna grab ahold of the muscle and pulls on there. It's grabbed onto the vein in there, it's actively fixated. So there's three electrodes beyond that in the vein and one more proximal to that. But just showing what it would look like inside of the vein there. Well how safe is that? Are we going to perforate the vein? I gotta be honest. The first time I looked at this and tried it in an animal and cadaver lab, I thought we were gonna be perforating all the veins. And it turns out it's not it's not that far of a separation of the helix from the lead. And if you look at this image on the left is pathology pathology image. You can see the lead, you can see the large vein that the that the that the active fixation helix is in. And it turns out the average distance between the vein and the artery. Remember veins and arteries run parallel was a More than or up to one or greater And the helix is only about 2.0.25 mm away from the lead. So The Helix is positioned again about .25 mm from the lead, about a four times safety margin between the artery and the vein. So we're not going to go nail that artery by putting this are actively fixating it in. So what are what have been the recent advances? Well devices are increasingly bluetooth enabled enhancing connectivity. Um This allows for more timely and complete remote monitoring. This was even happening before the pandemic but became obviously so important during the pandemic and continues to be and we have increased battery longevity of devices, smarter more automated devices, especially in CRT we have technology advancing to allow monitoring of more physiologic parameters, heart failure, eventually blood pressure and other things. We're seeing the evolution of leaderless pacing which we V V. I now ssv pace and eventually dual chamber pacing. Um and eventually CRT we'll see um unmet needs for LV leads have been addressed now with the active fixation lead and then of course physiologic pacing as we heard from Dr Donda moody which has its own science and and and and group and there's an annual physiologic pacing conference that is well attended and growing and growing because this is something that is is so important and helpful if we can just get the better tools and find ways to get that experience um even better. So um happy to answer any questions nick, not sure what time we have here. We got some time. So any questions or we can go right to the panel discussion, whatever is best. Thanks, john, Alright, we'll take care everyone. And it was, it was a pleasure uh delivering this meeting. Mm mm. Mhm.
