All right, good afternoon, everyone. Thank you for coming over to join our session. For those of you who were just in the AP lounge listening to Sam Sears, I hope you're still awake after a lunch, and he's a tough act to follow, but we'll do our best. Some housekeeping things. It is my pleasure to welcome you to San Diego and Heart Rhythm 2025, the 46th annual meeting of the Heart Rhythm Society. If you've not already done so, please download the HRS mobile app from your preferred app store. This is how you can participate in live Q&A during the session. We're hoping to have a really great discussion afterwards. Please scan the QR code on the screen to access this session's Q&A. When using the mobile app, log in with your HRS credentials. Please note that visual reproduction of the Heart Rhythm 2025, either by video or still photography, is strictly prohibited. So my name is Dana Goldinz. I'm a physician assistant at Beth Israel in Boston. It's a pleasure to welcome you. My co-chair, Brenda Smith, from Duke University. We have a great session on MRI and CIDs, workflows, and challenges. To begin, it's my pleasure to introduce Eileen Farrick. She's a nurse practitioner at White Plains Hospital, and she will begin. Good afternoon, everyone. Okay. Oh, here. Got it. Sorry. My disclosures. It's spinning. There we go. Okay. So I'm going to talk about the existing 2017 HRS Expert Consensus on MRI Imaging and Radiation Exposure for Cardiac Implantable Electronic Devices. So I thought I'd start because I don't know that everybody knows the physics of an MRI and how it interacts with CIDs. So you all know it's a noninvasive diagnostic technology that uses powerful magnets to produce a magnetic field and radio waves to create a detailed three-dimensional image of body organs. And the components of an MRI are the core, which is what the patient is in, a primary magnet, a gradient magnet, radio frequency coils, and the computer room, which is also known as the control room. And so how does an MRI scan work? So as you know, the human body is made up mostly of water, which is the H2O molecule, and there are proteins in the nucleus of the hydrogen, of hydrogen, and the MRIs use those protons. So protons typically spin in the body randomly, but when an MRI machine is introduced and static magnetic field is introduced, the protons align along their axis. When the MRI tech then introduces the radio frequency pulse, it disrupts that proton, forcing it to change its alignment. And then when the RF energy is turned off, the protons realign and they release electromagnetic energy. And that energy differentiates the various tissues in the body organs depending on how quickly it realigned. And that's how the image is created. And some definitions related to magnetic fields as we talk about the recommendations is Tesla is a measure of magnetic field strength. MRI scanners use different field strengths ranging from 0.2 to 9 Tesla. You might have heard of the term Gauss, which is also an alternative unit of measurement for a magnet. One Tesla equals 10,000 Gauss. And these magnets are incredibly strong. They are 4,000 to 60,000 times greater than the Earth's magnetic field. And 5 Gauss is what is considered safe magnetic field strength around MRI scanners. And you should also know the geography of the MRI scanner because that also is included in the recommendation. So zone 4 is in the actual scanner room. This is where there's a highest risk to the patient. And it also can be a risk of, you know, objects flying and thus there are specific screening that has to be done, removal of a lot of ferromagnetic, you know, instruments before you're allowed to enter the room. And then zone 3 is a space just outside the MRI scanner that also includes the holding area and the control room. And there is restricted access to that zone as well. Zone 1 and 2 is outside of the restricted area, reception area, public space related to the imaging center. All right. So what is the potential interaction then between CIEDs and the electromagnetic interference from an MRI? So first is the magnetic field-induced force and torque due to ferromagnetic material such as iron, nickel, and cobalt could theoretically move the device. Now for a CIED generator, the movement is very unlikely because it's confined in a subcutaneous tissue. And the leads don't contain ferromagnetic material. So there's no cause for it to move. Another interaction is the gradient magnetic field-induced electric current can induce current in the conductive wires which could lead to myocardial capture and potentially cause atrial or ventricular arrhythmias. A third interaction is heating and tissue damage. So those RF pulses that are introduced can lead to a non-conditional CIED component getting heated and that then can cause thermal damage in the surrounding tissue. So it's considered like a functional ablation. And changes in sensing or capture threshold can be the consequence of that tissue damage. Another interaction is read-switch activity. So we know that read-switch permits programming of a device with a magnet placement, right? So the magnetic field can also affect the read-switch in non-conditional CIEDs which could lead to asynchronous pacing or inhibition of tachycardia therapies just like we do, right, put magnets on. Another interaction is that the high-energy electromagnetic interference can lead to electrical or power-on reset. So that would put the device in a backup mode and that could lead to pacing inhibition or actually activate tachyarrhythmia therapy. It could also cause a power-on reset which varies by vendor and actually in the guidelines it's a table that defines what happens with the power-on reset. And that can switch polarity from bipolar to unipolar which can cause over-sensing of the MR signals leading to pacing inhibition. And the pacing can be occurring below the threshold in both unipolar and bipolar configuration and that can cause inhibition of pacing which could be catastrophic for somebody who is pacer-dependent. And we also know that the high-energy electromagnetic interference can cause a change in the battery status and that's why if a patient is close to elective replacement indicator that it could cause unreliable function. And then other inappropriate functions and therapies that are described are the EMI from again the RF pulsations or the rapidly changing magnetic fields could cause over-sensing again leading to inhibition or inappropriate inhibition of demand pacing leading to asystole. It can also induce therapy leading to an inappropriate ICD shock and cause other inappropriate tracking or programming changes. And just to define the difference between an MRI conditional device and a non-conditional device is an MRI conditional is any device which has been tested and it has a, in which a specified MRI environment with specified conditions of use don't pose any hazard. And that means that the device had to be tested including looking at that magnetic force and torque, looking at induction of current through the wires and that heating damage. And then other tests are also included to make sure there's no potential EMI from the MRI. Now a non-conditional device or all those that don't meet those above conditions that I just described. And it's also those MRI conditional generators that are combined with the non-conditional leads or as you know the mixed system from different vendors or systems with abandoned leads that are either capped or not, that have extenders, adapters, fractured leads, lead remnants or surgically implanted epicardial leads. Not the ones that are snipped after having open heart surgery but the actual epicardial leads that are placed surgically for older devices. And so what are some of the recommendations? I know these slides are a little tedious and I'm going to go over them not in great detail because our third speaker here today will be going into greater detail. And I don't know if you know the difference between recommended as a class one indication, reasonable as a class two, typically A and that's what you're going to see in these guidelines. Understanding the level of evidence that supports the recommendation. So devices should be considered MRC conditional as I said if they've been tested and labeled as MRC devices and that they are programmed into the appropriate MR mode when going into the scanner. Another recommendation is that we need to follow a standardized and rigorous institutional workflow that is in collaboration with radiology and other device specialists. That the device needs to be programmed to the appropriate MR mode. That sensing and pacing threshold checks should be done before and after the MRI. MR settings are activated based on the specific manufacturer specifications and I think one of the other speakers will talk about the automatic ones that are currently available. You have to decide based on the patient's pacing dependence whether they should be an asynchronous or a non-pacing mode. You're going to deactivate all the tachytherapies. Personnel skilled in basic life support and advanced cardiac life support should be in attendance while the device is in the MR mode. Pulse oximetry, EKG monitoring while they're in the MR mode. All resuscitative efforts need to be done in zone four because of the restrictions I previously described. So if the patient has a hemodynamic consequence related to their MRI you have to pull them out of zone four into zone three before resuscitation. And personnel skilled in programming CIED should be available based on what your specific institutional protocol has developed. And it's reasonable to do an MRI earlier, not have to wait the six weeks if it's based on a risk-benefit for the patient. So now recommendations for a non-conditional MR device. And the first thing I'm gonna go through is it's reasonable, so based on class 2A evidence, that there are no abandoned, epicardial, or fractured leads. That the MR is the best test for the condition and that there's an institutional protocol and designated MR-responsible physician who will be present for the MRI. Again you can perform the MRI scan immediately after implant based on risk-benefit and you can repeat the MRI without restriction regarding the minimal intervals, how frequently you need to re-perform the MRI. Today it's recommended, again, that the device be tested pre and post, that there be a defibrillator monitor with external pacing function available in the scanner holding area, again, zone three. Continuous CCG and pulse oximetry, the personnel, all of the previously reported recommendations. And it is reasonable to schedule a follow-up evaluation within one week after the MRI to evaluate for any of those changes from possible thermal heating, meaning their pacing threshold went up, their sensitivity is reduced, or their pacing or shock impedances have changed. And so just to sort of discriminate between if a patient is pacer-dependent, those skilled personnel need to be in attendance during the scanning if a patient is pacer-dependent, and a physician needs to be immediately available on the premises, and I think that's probably more for those lone-standing imaging centers, to be able to put in a transvenous temporary pacemaker. A physician who can direct the CIDED programming should be immediately available on the premises, and again, in this case, you're definitely going to program the device to asynchronous pacing and deactivate any of those advanced or adaptive features during the MRI. If the patient's not pacer-dependent, then those personnel that are skilled need to be available on the premises, not necessarily be in attendance, and the only other difference is that you can program to either a non-pacing mode or an inhibited mode during the MRI scanning, and again, turning off the other features that are advanced or adaptive. And with CRT patients who are not pacer-dependent, it's reasonable to program an asynchronous mode like VOO or DOO, with again, deactivating the other features. And there is a table in the guidelines that, I'm not gonna go through them all, but what the adaptive and advanced features that are required to be deactivated, there is a very nice figure that lays out everything that I just described, so that if you wanted to print it out and have it available in your clinic, it is readily available. There is a checklist for doing a pre-MRI testing and documentation of that. And more importantly, I'm very pleased to announce that there has been an update that will be actually covered tomorrow in a session at 3.30 to 4.30, with a call to action to improve MRI access for patients with CIEDs. So I encourage people who are really involved, which are probably most of you, how many people here complete those checklists and do all those? Yeah, probably 100%, pretty close. So what was the rationale for the call to action? So the 2017 guidelines are published, but there's been no recent update, so that's eight years old. CMS, after that was published, agreed to reimburse MRIs, limited to 1.5 Tesla, for the non-conditional MR devices. And that was based on new evidence that came out after the 2017 guidelines were published, including the guidelines as well. And currently, there is limited access, as we all know, for CID patients to undergo an MRI, despite evidence demonstrating that under appropriate conditions, it's safe to do. And there are no recommendations for the addition of other non-CIED devices, such as prosthetic valves, VSD closures, stents, heart valves, left atrial appendage occlusive devices, PA pressure devices, et cetera. So in 2024, the Heart Rhythm Society put together a task force, and they developed a member survey. How many of you filled out the survey? Yeah, a few, okay. And that identified the barriers and challenges that we're currently experiencing for getting patients to be able to have their MRIs with CIEDs. And what they found was, providers found that there was a limited MRI access, and patients who need imaging based on post-safety considerations, and that there's a need for improvement worldwide. And providers also found that there was increased effort, as you all know, workload, and dissatisfaction for the process from healthcare providers, because it is limiting. I know in our institution, they won't do MRIs on patients that are non-MR conditional, have to go to other sources. And there were restrictions impact patient care. There's a lack of clear guidelines, and there's issues with reimbursement. All that came from the survey. And then, I would love a show of hands for this, because I didn't realize this. But there was another impact of the December 2023 vendor-specific exclusions, where patients with non-MR conditional devices that had these other devices should be excluded from having MRIs completed. Did you guys know about that? Anybody know about that, 2023? Because I was not aware, but it is in the call to action that it was something that was established. And so, the call to action recommendations are two crucial ingredients to effect change. One is a collaborative, patient-focused partnership between device care and imaging teams to change the culture in both medical specialties, so that MRI scans are provided and become standard of care for all but the highest risk CIED systems. And that, secondly, an agreement on publication in unified set of clinical standards established by an international cardiology and radiology societies combined to provide one comprehensive document or pathway that establishes MRI scanning for CIEDs, again, as standard of care. And so, some of the recommendations that they are suggesting, again, this is a call to action paper. It is not a recommendation paper. That will be what will come from this, is that patients with MR conditional CIDs and other non-CIE devices, as I described, that directive from some of the vendors from December 2023, should not restrict patients from having an MRI. And that mixed device systems, that there is a suggestion to change the labeling with approval from the US Food and Drug Administration, and there is a Center for Device and Radiology Health that they consider changing based on the newer evidence. That we expand focus research for those abandoned leads and epicardial and array leads because it really affects a lot of patients who are pediatric and have congenital heart disease. That we advocate for workflow studies for MRI access. We advocate for more funding to do research on the interactions. That we agree to publish a unified set of clinical standards with a comprehensive pathway. That we revise the reimbursement for CIED testing. So the current call to action does have specific codes in there for actually testing devices pre and post that should be used. We want to establish a data registry so we can see in real life what is going on with patients' MRI and CIEDs and to establish a joint cardiology, radiology, MRI access in order to access team, in order to train people, and even go as far as certify people to be able to clear patients for MRIs with CIEDs. So that's their recommendations for call to action. And they actually have defined who they think should be part of the EP cardiology team and part of the MRI radiology team to provide this collaborative effort. And so in summary, although becoming obsolete, the call to action, and since the only guidelines we have are the 2017, do need to be followed. MRI access for CIED patients is essential, right, for accurate diagnosis and patient care management. We need to make changes based on current studies demonstrating safety in non-conditional devices as well as providing further research so that we have evidence-based practice management. The call to action is to collaborate interested societies, which include, again, cardiology, electrophysiology, and radiology, and internationally, across the boards, to establish the registry, to establish standard of care and workflow patterns, to have reimbursement reform, and to improve collaboration and cooperation with CMS for that reimbursement. And again, as I said, to develop a joint cardiology, radiology access team to establish those pathways, training, and potentially certification for clearing people for MRIs. And with that, I will turn the podium over to our next speaker. Thank you. All right. Thank you so much. Next up, we welcome to the stage Uloma Ijeoma from White Plains Hospital, and she's going to talk about establishing MRI CIED workflows. We'll do all Q&A at the end. We see some questions coming in. Please keep them coming. We'll address them at the end. Good afternoon, everyone. These are my disclosures. So today I'm going to be talking about establishing a CIED MRI workflow for your institution. And I'm actually going to zero in on my institution, a workflow, an MRI workflow that we established. Okay, so I'd like to start by just taking a poll and audience to see how many of you have an established MRI workflow in your institution. So, wow, that 91 percent, so I'm sure some of you can actually take this talk. So a huge percentage of you do have an established workflow. So I'm just going to go through what we've done, and if you misunderstand, our institution is a 292-bed hospital, it's a tertiary institution, and a division of the Montefiore, which is a big hospital system in New York, but we are based in Westchester County in New York State. So why do we need to establish a CID workflow? Aileen touched on some of the guidelines and recommendations, but we all know that we do experience a lot of issues with having the patients going for an MRI scan, there's some barriers that we establish and face in our institutions, and some of you may have been facing that as well. And some of the barriers will be like lack of protocols, but I see a lot of us here do have existing protocols, and there's room for improving those protocols. Lack of trained personnel or dedicated staff for MRIs, lack of interdisciplinary support, worried about the risk to the patient, perceived safety concerns, I still have patients that tell us that, oh, I was told I couldn't have an MRI done. There are also institutions that really will not do an MRI on a patient with a pacemaker or a defibrillator. Lack of equipment to monitor and support during MRI, and poor reimbursement to the hospital. So they don't see a reason why they would have a dedicated staff for that purpose to streamline the process and avoid delays in patient care in getting MRIs done. So we experience some of these delays or barriers, and we have an EP program that's about eight years old, so we're fairly young. So in 2021, we came together, the EP service, radiology, MRI technology and MRI safety officers, and sat down to come up with a workflow, a pathway that would eliminate some of the delays that were faced with patients having their MRIs scheduled. So we developed this workflow pathway based on the 2017 guidelines that was just talked about, mentioned by Aileen, and we looked at patients with MRI conditional CIEDs. So that's what we, our workflow applies to just patients with MRI conditional CIEDs. CIEDs that were deemed non-MRI conditional were referred to a different facility. As of date, we don't do the MRI non-conditional. We're working on developing that pathway as well. So basically, our MRI department receives the request for MRI. The MRI staff are able to identify and confirm if the device is MRI conditional, and a request is sent to us, the EP nurse practitioners and MDs. Mostly the nurse practitioners, or the APPs, do that, the forms and take care of this issue. The EP nurse practitioner looks at the device, patient's records, if a patient is MRI conditional, then they have the vendor-specific forms that are filled out, or an MRI order is placed in EPIC for the MRI department. The vendor for the patient-specific device is contacted to come in to be there for the MRI testing or scanning at that point. Now there's some patients that are not followed by the EP service at White Plains Hospital. So the MRI staff take it upon themselves to contact the following physicians. Most times they don't reach them. It comes right back to us, and then we end up ordering the MRI, placing the MRI orders. If there is no chest x-ray, we look at that to make sure there are no abandoned leads, the chest x-ray will be ordered. We have the vendor come in and interrogate the device so we actually know what the patient has, if the device is eligible to go for, if the patient has a device that's MRI conditional, and if the thresholds and within parameters for him to be able to have an MRI done. So patients, like I said, not followed by our EP service, again, the MRI staff takes care of that. So the orders are placed in the EPIC under the patient's chart or faxed to the vendors. We do also receive a lot of requests from outside facilities, from cancer centers for patients that are undergoing cancer treatments and requiring a lot of MRI scans to be done. So we do go through the same process, and the information is faxed back to the facility. So we do screen our patients for conditionality, and I refer again to the guideline from 2017. So we want to know what the device types are, the pacemaker, are they pacemaker dependent, are they abandoned leads, is it an MRI conditional, the whole system, when was it implanted, is it over six weeks, are the leads longer than six weeks, is the battery at ERI, what are the thresholds, are the leads all programmed bipolar, the impedance, we look at all that while we fill the forms. I don't have a sample of the form, but I'm sure most of you have seen that. So prior to MRI, the MRI staff contacts the vendor for the patient, and a full device interrogation is performed before MRI just to make sure that all the conditionality issues are met and the thresholds are within the normal for an MRI. We monitor the patients, there's pulse-ox telemetry to monitor the patient, and external defibrillator is also present there just in case for pacing and especially for ICDs there where therapy is going to be turned off. So you want to make sure that you have backup. So the MRI scan takes place, and post-MRI scan, a full device interrogation is performed as well. And of course, if there are abnormal reports, an EP consult is put in, and the EP service involved more, and the patient's referring physician is also made aware. And if normal post-MRI device interrogation, we just send them back to their following physicians and an ordering physician with the MRI results. So we also, this was touched by Aileen a little bit, just the programming mode, you want to make sure they're in MRI-safe modes for those that are not pacemaker-dependent and for patients that are pacemaker-dependent. And we want to also program them in asynchronous mode 10, some say 10 to 20 beats above their intrinsic rate. For patients with ICDs, you want to turn off all the therapies and detections prior to MRI. So for our institution, there's some of the streamlined process by the different companies that I'm going to just touch on here, which we could also implement. We're actually working on trying to get that implemented, but the MRI staff are a little afraid to be the ones to have to take care of the whole process. So this is still a work in progress for us in that area. So Medtronic has a Medtronic MRI Verify and MRI Care Pathway app. The MRI Verify allows you to actually check for MRI conditionality for patients with Medtronic device. That's actually the website where you can get more, you can type in the patient's device ID or search also by name and get more information. And then you have the Care Path app, which actually helps in verifying conditionality. So we would have shown to reduce from a 10-step process to reduce the process for the streamlined workflow to about four or five steps. So it streamlines the MRI scan workflows. And with the MRI Care Path app, the MRI technologists can actually use this tool to manage the scan without the presence of a device expert. But this is where they're really scared to be the ones to do that because they feel they're going to cause harm to the patient. So we're still working on that process. And it actually programs the device to the parameters needed. So we can do the sure scan on and sure scan off. And it will notify the healthcare provider if the device is not MRI, if an MRI cannot be safely performed for that device. So I think it's also a good tool to implement in your workflow if you haven't. And Biotronic has the Biotronic, they have a pro-MRI system check where they check their devices for MRI conditionality. They actually work with the MRI auto-detect or MRI guide, which helps. It's a feature, really, that once a patient enters an MRI field, it automatically programs the device to an MRI mode. It helps, you know, it has to be activated. And post-MRI returns it to its original settings. So this could be programmed and active in the patient's device for about 14 days, allowing for repeat MRI scans as needed. Sometimes you have patients with strokes that may need a repeat MRI scan just to compare from the previous. They also have what their life supports, which are some of their remote screen sharing tools where the Biotronic representative can receive real-time remote support, report for adjusting the MRI settings before and after the MRI. And then Boston Science uses the HeartConnect tool for MRI support, where the Boston representative can screen share a life in real-time. They can provide support to the healthcare provider to complete a device programming before the MRI and after the MRI. So the same premise. At the bottom, you can actually watch a video of how this process goes through. It's a good video on that. Abbott still has a manual programming, so no remote applications to assist during MRI. So the representative has to be there before, during, and after the MRI to manually program the device and also check the device after that. I believe they're working on developing something remote for their devices. So we just have a little workflow. We put in a little chart how we can look at that in summary of how our own hospital workflow for MRI. But we're working on actually improving this and also thinking about looking at non-conditional MRI scanning. And this is all in progress, in process. So in summary, I'll also go back to the guideline, which talks about the fact that an applied, standardized institutional workflow is necessary. An MRI workflow ensures timely access to MRIs and eliminate the delays in treatments that are being experienced. We have an improved patient outcome and reduce financial burden on healthcare institutions from delays, extended length of stay in the hospital. There's always room for improvement for an MRI institutional workflow. I always say, if you don't have one, or if you have one, you can take it as a QI project to improve what you have already. You can measure your outcome, how well is our MRI workflow at this point, identify areas that need improvement, and then you can also refine your workflow for better patient outcome. Thank you. Thank you so much. Our final speaker today will be Khadim Khadim from Freeman Hospital in Newcastle, UK. Thank you very much for the kind introduction, and to HRS committee for the invitation. Yes, this is not a typo. I do have the same first and last name. I have nothing to disclose. So Eileen has already very nicely covered this, but because you can never have too much physics, particularly after lunch, I'm going to talk very briefly about the physics of how an MRI image is acquired with a focus on the three forces that are at play that can potentially interact with the CID. So we hear that we all have tiny little magnets in us in the form of a hydrogen nucleus that are essentially positively charged protons rotating randomly. Then the first force comes in, which is the static magnetic field, and what that does, it aligns those protons. And then the second force, which is the radio frequency wave, that kind of stimulates those and gets them on their side, and now they're fully charged with extra energy such that when you release the RF wave, they release back that energy back to you. And the third important field is the gradient magnetic field that changes in intensity and location to allow you to have the spatial resolution and render a 3D image. And we've already heard about the potential interactions, and I like that you used the word theoretical because most of what we know about these is actually either theoretical in silico or in vitro studies. I like to highlight this mostly because it's cool, but also because of its reassuring message. So this is a biomedical engineer from Zurich reported about 25 years ago, and they had pacemakers and defibrillators suspended in a phantom in a 1.5 Tesla scanner. And what they found was that the force detected was lower by and large than the gravitational force of planet Earth, lower, underscore. So in general, a device can either be fully MRI safe or fully MRI unsafe or MRI safe if certain conditions are met, and we've already heard about these conditions. But largely speaking, they are the combination of a system, so the generator and the lead, where the generator is placed, how it's programmed, how much battery there is in it, and there are some parameters related to the scanner itself. And I'm going to focus a little bit about this, which is the absence of non-conditional components, including epicardial or abandoned leads. But patients with non-conditional devices have needed MRIs, and patients with non-conditional devices have been getting MRIs for a long time. And I don't expect you to read the tiny text, but I would like to highlight that the majority of the findings of these small case reports was that there have been no adverse effects. These are inherently biased in their design and the kind of publication bias, and therefore having the MagnaSafe registry was a really welcome step. So this is a landmark study, I'm sure most of us are familiar with, but essentially they prospectively recruited 1,000 pacemaker recipients and 500 ICD recipients who are having clinically indicated non-thoracic scans with pre-specified programming to ensure that the devices, which are all non-MRI conditional, were safe for a scan. And importantly, there were no deaths, lead failures, loss of capture of ventricular arrhythmias, was a single ICD generator failure, but that device was not programmed according to protocol, and there were some non-clinically relevant events as well. And I was a fellow in Adelaide, we looked systematically at this particular question, how safe is it to perform MRIs in non-conditional device recipients? And we did a meta-analysis, found 35 studies of more than 7,000 scans and more than 5,500 patients. The majority of the scans were of the head and neck region, but there was some variation, anatomical variation as you can see, and there was a very small proportion of patients with abandoned or epicardial leads. And again, what we found was no deaths, reassuringly, no ICD shocks, very low risk of lead or generator failure, and a small risk of non-clinically important findings. But what about the real world, we've all had requests. Well, I hope MRI requests for patients like these, we've seen those patients. So abandoned leads, in my mind, is the most sticky point, at least in my institution, as to whether a device is scanned or not. And some of the earliest data that we have comes from the Mayo Clinic. So before 2008, it was deemed safer to have a procedure to take out the generator, leave the leads where they are, perform the scan, and then re-implant the generator after. So essentially, you've got patients with no, just abandoned leads. Yes, almost unthinkable nowadays, isn't it? But that was the norm. But, and it also provided important data for us, in that there were no clinical, adverse clinical issues. More recently, and more comprehensively, from Pennsylvania, we have, I think, the largest dataset that specifically talks about patients with abandoned leads. This is 200 MRI scans in 140 patients, half of whom nearly are pacing dependent, and a good spread of where these abandoned leads are. And what did they find? Nothing bad happened. Okay, there were some changes in sensing that, by and large, normalized in follow-up. Interestingly, some of the sensing changes were in the chamber, not where the abandoned lead was. So I don't know how they can concile that. And there was some, one reported symptom of sternal burning, but again, subsided when the MRI was stopped. Now, despite the abundance of data as to the safety of performing MRIs, both in conditional and non-conditional, and the growing need, there is a hesitation, if not reluctance, to provide this important service to our patients. It is estimated that nearly half the centers in the UK that are capable of providing MRIs do not do so. So recently, the British Heart Revenue Society, along with the Royal College of Radiologists, and importantly, patient representatives, came up with this consensus document, which, as we've heard, kind of outlines what needs to happen, who needs to be there before, during, and after the scan, both for MR conditional and MR unlabeled scans as well, with the addition of a risk assessment, and ensuring that the right personnel are present during or after the scan. Of course, it's a European guideline, and no self-respecting European guideline is complete without a traffic light system, so this doesn't disappoint. What I would like to highlight is that most of the scenarios, which I'm not gonna go through in detail, actually fall in the lower risk, lower or lowest, and I think it's reasonable to say, avoid scanning if you haven't programmed the device properly or you cannot do so, otherwise, you pretty much can scan everyone, depending on their risk, and that's what we've been doing at the Freeman Hospital. So, the Freeman is a quaternary center. We do heart transplant. We have pediatric and adult congenital as well, so we've been needing to perform MRI scans for some time, and our workflow simplified is like this. If an MRI request identifies a CIED recipient, the radiology department liaises with the cardiac rhythm management department. If the device is MRI conditional, then the scan is booked in a physiologist-supervised list. We don't have reps, so this is all in-house physiologists. We check the device before and after, and we don't need consent. The patients are provided a patient information leaflet. If the device is deemed non-conditional and falls in the low or lowest risk, then it's pretty much the same process, but with the addition of obtaining informed consent from the patient, and that can be performed by either physiologist or the radiographer. If it's medium or high risk, and these are just examples of what we would deem as medium or high risk, then that goes back to the radiologist to see if there is an alternative way of answering the clinical question, and often there is liaison with the farer, and if there is another modality that can answer the question, then happy days, that scan is booked. If not, then it's a cardiologist-supervised list, and we do about one a month of these. It's usually in the morning, and we were talking earlier, it's my opportunity to catch up with my admin and emails while I hear the beep, and if the beep goes, oh, it's fine, okay, we just carry on. So that's pretty much what we do. We've also been keeping a prospective registry of all these scans with checks before and after, and we tend to think of our scans in four categories, so fully MRI conditional systems or mixed manufacturers. These are conditional components, but mixed and matched. Group C is non-conditional systems, and group D is the highest risk with the epicardial or abandoned leads. We've been doing this since 2012, and over 11 years, we've done more than 500 scans and nearly 400 patients, the majority are men. All of them are in a 1.5 Tesla scanner, because we pretty much can get the answer in those, you don't need a higher field scan for these, the majority of the scans are of the spine, followed by the head and other regions. You can see the studies year on year increase in the service provision. And again, similar to previous colleagues, we have found that there has been no events of death, clinical adverse events, lead or genitive failure, electrical reset or arrhythmias. So in conclusion, I would like to say that MRIs and CIDs are very largely safe, including non-conditional devices, and yes, including abandoned or fragmented leads too, as long as you monitor and program appropriately and respect the magnets. Thank you very much. Thank you. Okay. Does anyone have questions they would like to come up and ask? If not, we'll go through the questions that have come online. Uloma, someone specifically asked you, when your office doesn't follow the patient's device, does the rep check, or is it on the day of the MRI, or is the patient brought into the office prior? The rep checks the, if the patient is inpatient, then they have the rep interrogate the device, and so we have the information on the patient's device, and then the MRI can be scheduled. Sometimes we've had patients who have brought in outpatient or office visitor schedule, but most times those MRIs are ordered and they needed to be done right away, so we have the rep come in and interrogate the device. I don't know if that answers the question. So based on your MRI protocol, what do you do for biotronic devices, which usually would not have a rep in-house? So we still do, we still have the reps, they turn on their MRI, the auto-guard, where it's on for like two weeks, because then they have the patients come and follow up in the office. So we haven't fully implemented the automated systems. This is, again, like I said, we have an MRI department, I just don't want to own that, so that's still a talk being discussed. So we still, most times, have the reps come in to have it done for us, yeah. And we have the question of who monitors the patient's rhythm during the MRI, the device nurse or the MRI nurse, and at Duke, we're very fortunate that our radiology staff do that monitoring. Yes, sir? I have a comment more than a question. So what we found when we were trying to implement this kind of system and have the reps called in to handle these reprogramming, program before and after, is that they were ending up canceling a lot, because it's such a low priority on them. I mean, they don't, they're not getting sales from that or any of those kinds of things. And so it got to the point where it was almost, we were getting a lot of patient complaints back to us, like it's our fault, and so I worked with the radiology department, and we actually blocked out a day, one day a week, where we just bulk schedule. I block my device clinic schedule completely one day, and then I'm just hanging out over outpatient MRI all day long, and then we just cram in as many as we possibly can. And by doing that, it's done a couple of, well, it's done a few things. One, it's improved our customer service, because those patients aren't getting canceled and rescheduled multiple times after waiting such a long time to get their MRI. And two, it's helped me learn a lot about what's all happening with an MRI. I had really had no clue, and so it's really helped me with that as well. Most of those patients that I'm seeing are my patients that I see routinely anyway, and so it's really reassuring to them to be like, oh, I know that guy at least in this scary department. So that's another big help. And so I just wanted to kind of give that as an idea, because it's really, really helped us, and we get the bill for it. Whereas before, when the reps do all the programming, you're not capturing those charges, and I capture those charges. So anyway, just wanted to bring that up. Yeah, thank you for sharing that. I think all of us in talking before, we're talking about the inefficiencies inherent with this whole endeavor, and so I think all of us have mentioned to some degree having block time, especially for those elective routine outpatient scans. You have your Friday off-label. My institution, Beth Israel, we have two set blocks where, same thing, I can sit there, I can do the programming for the off-label, and then we use the Medtronic SureScan app as well as the Biotronic Auto feature is nice, but that only is in the newest generation of devices. But I think efficiency is totally the way to do this, is trying to have a set day or a set time period so that you can try to cram all those people, and we can generally get 10 scans done in about eight hours for device patients in a week. And that's come up and helped our efficiency a lot. Yes. I was just gonna say that I think that's the whole reason for the call to action. Is to develop standardized approach where radiology is cooperating with cardiology, and cardiology is cooperating with radiology. Yeah, so I'm hoping that real straightforward workflows and guidelines will come out with the newer evidence that, as Dr. Kading was demonstrating, a lot of this is theoretical. I'm looking at the questions, people saying that research don't happen anymore, but these are the guidelines we had based on the evidence. And medically, legally, you really do have to follow the guidelines. And so we're stuck with that until we can update them based on all of this new data. So just a quick statement about the 2017 guidelines. They do have the phrase in there that exceptions can be made. Okay, so medically, legally, I work in pediatrics. I use all off-label devices. None of my stents are on label. Nothing is, so you can do it. And if it's under the right circumstances, I love the new guidelines that are coming out of Europe. That's wonderful and we need them. And I am the person, I'm that guy who talks about, when I have a student, when I have a resident, when I have a fellow, I always say the same thing. We do not deny care for theoretical risk without evidence. Because denial of care can hurt people too. I totally agree. So we can all agree on that. So that's why we have a non-conditional protocol. But it's based off of that little exception statement that exceptions can be made and that we determine between radiology and cardiology that that, it was reasonable. I think you're lucky that radiology accepted that. It's a fight. It's been a fight every year. In many places, radiology would not accept that. And read switches, physical read switches don't exist anymore. But this is like the airlines, right? We have seen airline crashes and they find out that there's a switch or there's a metal panel or there's a lever that causes a problem. And we found that out with the early generations, 2,000 generators, and we took that out. We took out the physical read switches. We have magnetic detection where it will automatically go to an MRI mode or some sort of thing. So that's the thing that when we're talking to patients and families about it, we have people really worried about it. And they're looking at studies from 2015 and 2014. But those generators were all implanted in 1998. They don't exist anymore. So it's interesting, though, that the 2017 guidelines kept that in, if it, right? Because they just didn't, like you said, they don't have any data. So that's so wonderful to see your perspective data. I'm loving it, thank you. And thanks. Can I add a comment? I appreciate that the UK kind of has a different healthcare system and the litiginous culture is very different, but as long as there is a shared decision making and there is an informed consent process going on, I can't see a problem, particularly, the only problem I see is denying care, as you very rightly said. So when we were doing this before all this data happened back in 2001, 2002, it was built on that kind of principle that this will change management and will help. Let's have a chat about whether you wanna take that risk, that's theoretical or not, and that's how we built up the data. Thank you. So this is just more of an observation, essentially, at my institution with the non-conditional program and conditionals, is actually issues with concomitant devices. We have patients who have pacemakers, and now we have a bunch of patients who have the CCM and the barostim. That has actually caused a restriction here because of the actual MRI machines themselves requiring different equipment. A coil transmit receiver, which not every MRI machine has at your institutions, and that has actually caused another roadblock that we ran into. We have patients, well, we have it for the 3T, well, barostim, CCM, sub-QICD, they're only good for 1-5s, so now we have this whole new non-conditional system to see is it risk-willing to do it on the 3T scanners, because 1-5s are really being phased out just because the 3T scanners have gotten much better. So that is an issue of concomitant devices, so I hope you guys are bringing that up, the call to action. That is part of it. Thank you. It is part of it, yes. And I think if you go to, I was a little restricted because these documents are embargoed, and so it will be fully discussed tomorrow. I think I said in my slide, it said 3.30, but yeah, I think that will definitely be addressed. And I think the other one, too, is actually lead lengths is the biggest issue that we run into now, especially on LV leads. LV leads are longer than standard RV and HRL leads, but for some reason, not every company doesn't submit their entire portfolio, so now we have these one patient who have a complete conditional system with an LV lead that also gets disabled because of the MRI mode, and that all of a sudden creates a whole crystal ball with the patient. It's like, I was told this is a conditional system. They don't see the lead length, whoever checks it doesn't see the lead length, and this creates a whole new problem. When literally the length is longer than any RV lead, it's not actively fixated to the heart. It's literally laying on the heart, so you're less likely to have any kind of, so that actually becomes an issue, and I hope that's also brought into call to action because that has become a roadblock for some of our patients. It's not, but somehow I feel like that's gonna fall in the category of getting funding for more research, so we do have evidence to adjust this guidelines. I don't wanna call out specific companies. I really don't wanna call out specific companies, but really there's one company that only has four leads out of their entire portfolio, and that has actually caused major issues because of how stringent our radiology is about adhering to guidelines, even though we know, hey, MRI mode on three of the companies turns off the LV lead. It is never active at all during that scan, and so that actually does become a massive issue for these patients, and especially because some of them drive like four or five hours to come to our institution, and all of a sudden we have like, oh, we have to do this whole workup now because technically you're non-conditional, and that actually becomes a massive issue, so distance plays a major factor, and then also not every institution has access to the resources and tools and personnel to set it all up, so there are aspects that are massive roadblocks for something that's literally conditional just because it wasn't submitted by a company, so that's another problem that we've noticed at our institution that hopefully does eventually get addressed or can be included in the call to action because that is a roadblock. All right, we're gonna wrap up and thank everyone for coming. The panel members will be around if anyone wants to chat. Thank you much. Have a good rest of the meeting.

Heart Rhythm Society

MRIs

Cardiac Implantable Electronic Devices

CIEDs

guidelines

MRI workflows

interdisciplinary cooperation

device labeling

conditional devices

safety