My name is Molly Sachdev, and I, along with Tim Larson, are going to be moderating this session. So, we're glad that you were all able to be here this afternoon. The topic for today's session is to talk about cardiac implantable devices and some of the challenges we all face in terms of obtaining MRIs in these patients. We have a great lineup of speakers, and we are going to be starting with Dr. Russo, who comes to us from Scripps Research Institute, and I'm sure you will enjoy his talk. Thank you. Thank you very much. Well, it's my privilege this afternoon to present to you what the data tells us about the risks of MRI in patients with devices. In background, given the yearly volume of pacemakers and defibrillators, there are about two to three million patients in this country, and around six to eight million worldwide. And many of them are non-conditional, because due to mixed system, mixed component systems. The problem is, after placement of a device, it's estimated that about half to three-quarters of patients will have a clinical indication for MRI. The problem, then, is MRI has become the imaging modality of choice for many anatomical positions, and disease states without an acceptable alternative. Now, in order to talk about the risks of MRI, it's important that we first define the risks and understand them. And those are lead heating, generator damage, unintentional cardiac stim, and the avoidable problem of inappropriate programming. So first of all, lead heating. A cardiac lead placed within a pulse magnetic field may result in a bidirectional transfer of RF energy and gradient field energy to the lead myocardial interface. The resulting thermal injury may cause either edema in the short term or fibrosis in the long term. Now, previous authors have documented extraordinary increase in heat at the lead tip of maybe 20 degrees centigrade, although troponin level increases were never really demonstrated in animal and human models. This was assumed to be the primary risk of MR exposure for patients with the device, although never really documented in clinical investigations. The potential risk of generator damage is that when exposed to a static or dynamic powerful magnetic field, that retrograde transmission of RF energy from a pacing lead to the microprocessor in the internal circuitry could damage the generator. Now, previous authors had taught us that devices that were manufactured after 2001 could be exposed to a magnetic field without reset or damage. And this was assumed not to be a risk to patients, and there's a reason. And the reason is that the pacemaker industry, looking ahead in 2000, with the advent of ubiquitous cell phones, had installed filters, through-pass filters, so that the cell phones of the day transmitting at 800 megahertz and then eventually using different technologies up to 1,900 megahertz are all blocked at the same time with those filters, with the frequencies that are emitted by 1.5 and 3 Tesla. So industry unwittingly had protected the devices for us many years in advance of any of our investigations. The third potential risk is RF-induced arrhythmia. The mechanism is that the pacing lead can absorb the RF frequency and graded energy as well with a bidirectional transfer of energy. Then the electronic components within the generator, that is the integrated circuits, can act as a rectifier. And at the bottom, you can see that the RF pulse undergoes conversion, rectification, with removal of the carrier wave and with the resulting modulating wave at a much lower frequency that has the ability to capture the myocardium. Another potential risk that I think is fairly obvious, and that is, should we, a generator or a lead, an abandoned lead, ever be replaced with MR conditional components to facilitate MRI. And even at experience centers, the major event rate may approach 3%, including emergency surgery and death. And in addition, even for an elective gen change and a lead addition, for minor events, that may exceed 4% to 15%, thus. Lead extraction, generator replacement, represents an unacceptable and unnecessary risk if performed only to facilitate MRI. In addition, unfounded concerns regarding the safety of abandoned leads have made pre-scan chest X-rays and interpretation an unnecessary requirement for access to MR. Now the avoidable risks are inappropriate to programming. For those pacemaker-dependent patients, either failure to reprogram to an asynchronous mode or simply not identifying the device beforehand, having it inhibited by brain sequences especially. In the ICD patient, failure to disable tachytherapy and sensing can lead that device to fail because of its inability to form capacitor and then recognizing the fast sequences of brain imaging as VTVF. Resynchronization therapy patients should all be recognized and treated as if they are pacemaker-dependent. Otherwise, at a lower pacing rate, hypotension may complicate the scan. And lastly, even though 30% of all MR patients are not pacemaker-dependent at all with a very low pacing burden, inappropriate asynchronous pacing has the obvious potential complications. Now in going through the literature, especially for this talk, there are more than 400 publications in PubMed looking at the risks of MR in patients with pacemaker defibrillator in the English language over the last 15 years. Guideline documents, surprisingly, for the performance of MR with the device have been published by at least 10 cardiovascular and radiological societies worldwide, creating much confusion. In chairing a writing session recently and writing a research protocol for MagnaSafe 2, I whittled that down to about 30 significant articles, of which there are only four fundamental articles from which everything stems, both pacemaker risk and abandoned leads. So let's start with MagnaSafe, a multicenter registry of 1,500 patients to determine the risk of MR for both non-conditional pacemakers and defibrillators, and to define a protocol for screening, monitoring, and device reprogramming. After enrolling 1,500 patients, there were no deaths. There were no lead failures or loss of capture for pacemaker-dependent patients. One ICD failed because they entered the scanner with tachytherapies active. There are a small number of arrhythmias and electrical resets. Let's look at the atrial arrhythmias for a second. Total of six out of 1,500 patients experienced AFib. There were no ventricular arrhythmias during the study. Five of the six had an established history of atrial fibrillation, as you can see on medical therapy. One patient did not, and the AF resolved within 48 hours. When we look at secondary endpoints, a small change in predetermined endpoints as they relate to battery voltage, pacing thresholds, PNR wave amplitude, and lead impedance were seen in a very small number of patients. But none of these actually were seen as an increase in adverse events. The question that needs to be answered, and that is, what do these changes actually mean? The top two panels are patients who underwent MR and then were, of course, one hour apart, were re-interrogated before the device was re-established. And then the bottom two are control patients who only underwent device interrogation at Pacemaker Clinic and came back an hour later. As you can see, although I've only presented P wave amplitude and R wave amplitude, there is a natural distribution of these numbers, and that's true of everything, including impedance and battery voltage. So the conclusion one should draw, and remember, that changes in device settings after MR may be due to RF energy or gradient exposure or maybe simply represent measurement variability and short-term fluctuation, as you can see in the control group. One thing I was unprepared for in this population is the number of patients who undergo repeat scans, which is approximately 15%. And as you can see in the number of Pacemaker and ICD patients, most of these people with repeat scans underwent that study as a result of a brain malignancy or abnormality. But the greatest number of scans in the defibrillator patient was 7 and 11 in the Pacemaker group. When you compare the patients who would be most vulnerable for an RF-induced Pacemaker lead thermal injury with those who have only had one scan, there was really no difference between the two. And therefore, there is no risk with repeat MR scanning. To change gears for a second, the Hopkins experience was also published in 2017 by Semen Nazarian. The purpose was to evaluate the safety of an MR protocol with patients with a non-MR protocol device, a prospective single-center experience of 1,500 patients with 2,100 clinically indicated scans, 28% of which who had a repeat scan. They were either reprogrammed to an asynchronous or an inhibited mode. And these patients were the excluded patients who had a device placed within four weeks but did allow chest scans. No clinically significant long-term events were reported. And in a small number, there was electrical reset, both partial and full. And most of these patients were at battery end of life. Now the literature as far as abandoned leads is quite thin. This is probably the best review article, although it excludes the University of Arizona experience as well as the Halperin experience at Hopkins yet to be published. Twenty-one publications, 929 scans. Only two small number of patients had troponin after the scan. And there were no adverse events and no inappropriate pacing. So while remember, while abandoned leads are not included in the 2018 CMS memo, this is a result of insufficient data and not due to a documented risk of MR. Lastly, I'd like to kind of finish in the next couple seconds. The HRS call to action was published, I think, within the last few minutes. In 2017, HRS published an expert consensus statement. And despite efforts by HRS and many national societies, patients with devices have access has remained challenging, many with limited or no access. So in response to these concerns, HRS convened a task force in 2024, and not only to review recent data, but also to survey membership. As a result, the board of directors asked that the scientific statement of call to action be published, which was, as I said, today. While there are many aspects of it, I'm going to briefly touch on the last, and that is the EP partnership with the radiology community. This cartoon shows us that the collaboration between both radiology and cardiology is vital to maintaining and expanding access to MR care. On the right, the MR team is a radiologist who is concerned only with the scan. They're a paraprofessional who is not involved in the cardiovascular care of the patient, whereas the cardiology team includes a supervising MD who will determine pacing, rate, and mode in an appropriate level of supervision. A non-physician-based provider who is there to observe the patient and reprogram as well. And importantly, this does not include a device manufacturer representative for clinical decision making, patient observation, or device reprogramming, which I cannot say more strongly. The HRS call to action proposes this HRS-sponsored cardiology radiology team certification, a half-day in-person course provided at national meetings. After attendance, 10 cases will be submitted, at which the center will then be HRS certified for the performance of MR for patients with the device. Then this combined team will not only use the latest consensus statement from HRS, and in this country, CMS and CD, but it's recommended that no other document be used to confuse the landscape. So lastly, in conclusion, device or lead failure in patients with non-MR conditional devices does not occur in anyone who underwent MRI at 1.5 tesla, as long as they were screened and reprogrammed appropriately. Changes in device settings were noted in a small number, few exceeded specified limits. None resulted in an adverse event. Abandoned leads have never been associated with an adverse event, and the HRS call to action is now available, and hopefully an expansion and preservation of MR access for device patients who are dependent upon our cooperation and ongoing research so that no device patient who requires MRI will be denied access. Thank you very much. That was a great talk. Thank you very much, Dr. Rousseau. That was a great talk. And also, thank you for your leadership in this, drafting the scientific statement. Any questions that arise, please submit to the QR code on the screen, and we'll address these during the question and answer session at the end. Now I'd like to introduce our next speaker. It's Martha Ferreira, who's going to be speaking on CID clinician's role in off-label MRI scans, necessary service, or unnecessary burden. OK, great. Hi, everyone. My name is Martha Ferrara. I am a family nurse practitioner and the assistant director of EP services at White Plains Hospital in New York. So I was asked to speak about the clinician's role in off-label MRI scans in CIED patients. Is this a necessary service, or is this an unnecessary burden? I have no disclosures for this presentation. So cardiac implantable electronic devices, or CIEDs and MRIs. In the beginning, if you had a pacemaker or a defibrillator, it was an automatic no MRI. Before 2000, some incidents were reported, irregular ICD function, device malfunctions. And in the 80s, 10 deaths, about 10 deaths were reported in this patient population. But this was poorly documented data. So these were suppositions and conjectures. Was this an arrhythmia-driven death? The exact nature of this interaction is unknown, and the ideology is it was inconclusive. There was a culture of MRI-denied policy across the land. These were absolute contraindications. They were inflexible. You could not have an MRI if you had cardiovascular device. So there are estimates, as Dr. Russo said, 50% to 75% of patients with CIEDs will need an MRI in their lifetime. So this huge gap in patient care began to evolve. This gap continues to this day. So what is the big fear with MRI anyway? So we know that, or we think that the MR imager does not mix with a CIED. MR is an imaging technology that can provide better contrast in soft tissues, uses static magnetic fields, uses rapidly changing magnetic field gradients, and also high-frequency pulses, radio waves. So what are the fears? What are the concerns? Firstly, device displacement due to the ferromagnetic components in CIEDs. Also that enormous mechanical force and torque that that magnet can elicit. So that we know CIED lead tips have no ferromagnetic components. The other fear is the reed switch closure, which can be activated by a static magnetic field, placing your device in magnet mode. Also withholding ATP therapy in CIED patients. And the old fear, power on reset. That is a fail-safe factory setting default that can place that device in an inhibition pacing mode when the battery is detected to be below critical level or some damage to the circuitry. Now this inhibition pacing mode, it's a unipolar signal. And that unipolar signal can pick up EMI, which can be read by the device and deliver inappropriate tachytherapy or inhibit pacing, which makes your pacemaker-dependent patients very vulnerable. So that I would understand in doing this presentation what the FDA terms mean, no pacemaker or defibrillator has been termed MR-safe by the FDA. MR-safe is an object that poses no known hazard in all MR environments. And MR-conditional is an object posing no hazard in a specified MR environment and condition. That will become important. MR-nonconditional was a term first used in the 2017 HRS MRI guidelines. These are objects not deemed MR-conditional or safe. MR-unsafe speaks for itself. We're basically talking about pacemakers manufactured before 1995. So we all began to notice this evolving gap in patient care. Medtronic introduced the first MR-conditional pacemaker, the Revo pacemaker, in 2011. I remember this abstract in 2013 presented at HRS. Dr. Russo, I pore over this abstract with a later publication in 2017, the MagnaSafe Registry, which, as he explained, as he eloquently said, it was 1,500 patients that were assessed for the risk of having an MRI. And these were non-thoracic 1.5 Tesla MRIs, which showed that there was no device or lead failure that was reported. In 2017, again, Dr. Nazaria, in a 1,500 patient cohort, also did thoracic and non-thoracic 1.5 Tesla MRIs in this patient population, which showed that there was no reportable adverse events. So armed with this data and some single center studies, CMS actually began to reimburse non-MRI conditional devices, which are also called legacy devices, under specified conditions. They provided a nice checklist that it's just basically about keeping that patient safe while that MRI is going on. Please note that MRIs that had devices that had fracture, abandon, or epicariate leads were not reimbursed by CMS, not because there was a danger doing MRIs in those patients, but because there was such lack of data showing their safety. What is an off-label MRI in a CID patient anyway? An off-label CID system is a system that has abandoned leads, fracture leads, epicariate leads. And as of 2013, we began to hear things about mixed vendor systems. In 2018, Dr. Padmanabhan published a study in this patient with MRIs, legacy devices, and abandoned leads, again, demonstrating that there was no evidence of any myocardial injury, any adverse events. As recently as June 2024, there was a meta-analysis that was published, again, MRIs in patients with epicardial and abandoned leads. Now, again, there was no reportable adverse events. My incredibly great colleagues share their MRI protocols that they have at their institutions and have been doing this for years. Dana Goldens, who chair a session at this HRS, has been doing off-label MRIs for years. The fabulous, fabulous James O'Hara, thank you, James, also share his protocol where they do MRIs for this patient population. And his crew published a study about MRIs in mismatched vendors with no adverse events noted. So why is this gap still in 2025 for our patients? CIED recipients in the US are over 2 million. One in two of those patients will need an MRI in their lifetime. MRIs are anywhere between $1,000 to $5,000. Data from EP studies and other disciplines show the overall safety in this patient population. CMS changed their coverage rule in 2018. There are updated MRI guidelines from societies that are available. Many health care organizations, like James' organization, they have protocols in place that allows them to do MRIs in this patient population. Industry has improved the technology in CIEDs, and there are novel techniques from the MRIs that have developed really great techniques to reduce the artifact from CIEDs. Why this continued gap in care? Some of the reasons that I have found that are more prevalent is lack of personnel, lack of technical resources, gaps in up-to-date evidence. What I think is the most important one is institutional fear, fear of liability, complacency. This is the way we've always done it, so this is the way we will continue to do it. The position statements that I alluded to in 2021 from the Canadian Heart Rhythm Society and the Joint British Society in 2022 have updated their guidelines for MRIs in this patient population. I got this graph from the ACC, which shows you very clearly, very comprehensively, and elegantly. If you want to set up a workflow for MRIs in this patient population, this is the blueprint to follow. This is the one I'm walking into administration when I come back to New York, just to let them know that it can be done. I have colleagues who are doing it. We do not have this workflow at White Plains Hospital. So to answer that initial question, what is the clinician's role in CID patients needing MRIs? Well, what is the clinical value of MRIs anyway? So they do have better contrast in soft tissue. They have more accurate data that help us guide treatment for that patient, cardiac MRI for heart structure and function. There is value to the clinical team to guide us in that plan of care. You want an accurate, targeted treatment plan for that patient. And patients have more confidence in a plan that can successfully address the relevant clinical question that they come to us for. So I have a patient, a 36-year-old Hispanic woman, pacemaker dependent, that needed a cardiac MRI. Couldn't get it at my institution, so I sent her elsewhere. That institution gave her some sort of obscure reason as to why they could not have it. This is a 36-year-old Hispanic woman. We need to have a team-based approach to do this. More importantly, I think that there should be collaboration. There has to be a collaborative team approach, because I needed to call that MRI department at that other institution, speak to the MRI supervisor. Then I needed to speak to the assistant director in the radiology department, all the way up to the director of that department to get that cardiac MRI for my patient, who was upgraded by my attending EP to a CRTD. You need data. You need good testing. You need to know what you're doing for your patients. The stakeholders at this table, I think, are the patients, the cardiology, radiology, and electrophysiology teams. What's missing from here, in my humble opinion, is the administration team, because they're going to listen when all this ka-ching, ka-ching, ka-ching walks out of that door when I have to send my patient to another institution for an MRI. I think that the secret sauce to creating this workflow for your patients that need an MRI and they have this type of devices, abandoned leads, fractured leads, mixed vendor leads, their legacy devices, that secret sauce is an ally professional champion. I can only speak of James O'Hara, Dana Golden, Soya Sher, all these, oh, Shailene Gonzalez, all these AHPs have championed this workflow in their institutions. And they have been doing all these MRIs for all these patients for years, making tons of money for their institutions. So to answer the question, it is a necessary service. We need to answer the clinical question for our patients who trust us to continue the work that they need so that they can just walk in and have an MRI and get a plan of care that will keep them healthy. That is what we're here for. Thank you so much for letting me speak on this subject. Thank you. Thanks, Martha. That was a very passionate talk. Next up, we have Mark Fellman. He has extensive experience working with the FDA, I think 15 years or so. And he will talk about some of the regulatory considerations with obtaining MRIs in these patients. Do we have time for one more question? Two questions. OK, great. Good afternoon. These are my disclosures. I have no conflict, but I do want to emphasize that I'm not representing FDA today. I have a former experience at FDA and as a regulatory consultant. I wanted to talk a little bit about FDA for those who don't really know. FDA is located in White Oak, Maryland. Everybody has heard that there has been a reduction in staff there. The White Oak campus houses the Center for Devices, Biologics, Drugs, and Center for Tobacco Products. The premarket review teams are essentially intact, but they've lost a lot of folks from RIF in the communications and program offices. So it has been difficult there. One bit of good news is that they have been recently allowed to resume some work at home two days a week, like pre-COVID. The cardiac devices are reviewed in OHT 2, and implantables are in team 4. One thing I like to emphasize is that the folks at FDA, they're not bureaucrats and, I should say, politicians. They're just scientists. They look at the data. They're medical doctors, veterinarians, specialists. And they look at the data that's submitted, and they follow the FDA medical device regulations to establish safety and effectiveness. So I'm not going to go into a lot of details about the general concerns for MRI and implantables. It's been talked about a little bit, but there are mechanical effects, potential programming effects, device malfunction, and image artifacts. Specific to the CIED systems for pulse generators, there can be mechanical damage or displacement. These are potential risks, reprogramming, unintended energy delivery, battery damage, read switch. For leads in particular, there can be tip heating, potentially, tissue injury, which could potentially result in increased capture thresholds and decreased battery life. And then there are additional concerns for abandoned leads, fractured leads, epicardial leads, and other implantable devices that may be adjacent to these systems. Over the years, the companies have got very good at adjusting the design of the systems to accommodate MR conditional safety. That includes reducing the ferromagnetic content, updating to filters and shielding, programming modes specific for safe MR scanning, and then device labeling that describes the specifics of the systems that's been evaluated and the conditions that are being found to be MR conditional safe. FDA issued a guidance document in 2023. This is applicable to both passive and active implanted medical devices. The testing, again, is specific to each system and specific parameters for the MR system and its settings. The guidance includes definitions for MR safe, conditional, and unsafe. And it's acknowledged that the list of MR conditional requirements is pretty extensive. You've probably seen them on your checklist. But it's important because that's how the systems were evaluated. That's the data that FDA has reviewed. And that goes into the labeling. Under these conditions, it was found to be safe for MR. These are the definitions. You've seen them before. The current systems are MR conditional, which means for the systems evaluated, they've been found safe under these specific conditions. FDA recognizes a number of standards that help industry understand what the requirements are that they expect for testing. ISO 10974 and PC76, a subpart specific to active implantables, are important standards for both industry and FDA. The expected evidence submitted to support MR conditional labeling is fairly well-known at this time. Originally in the 2010 timeframe, clinical data was included to support MR safety. But over the years, additional information and knowledge has been gained. The current expectations are numerical methods and computational modeling, includes bench testing and phantom testing, and sometimes animal studies. The testing can be different for the different companies. But once it's submitted and found to be validated and acceptable to FDA, then oftentimes that's the testing that's repeated for new traditional systems as they come in, whether it's a new device or a modified system. So at this point, pretty much all of the company's new products are labeled MR conditional. And it's important there on the bottom left that the conditions are different. So every system is evaluated through a range of conditions. And it gets the labeling specific for what was tested. On the right side, it's important, again, that it's a system that's evaluated. And I know there's been a lot of talk about mixed systems and what to do when you have conditional pacer, but the lead isn't a matched component that was tested. And FDA doesn't comment on that. In the labeling, they say, this is what's safe. We've tested a system. We've evaluated the data. And we found that under these conditions, it is safe. And that's how it's labeled at the bottom there. FDA, they don't regulate the practice of medicine and don't really comment on what to do when MR conditional systems are not found. I'm not going to talk too much about this because it's already been covered a little bit. But there are certain steps that are expected to be followed in the lab. Confirming that the system is conditional, confirming the settings are correct, putting it into the safe mode, the typical steps, prescreening, programming before and post follow-up. And then these potential concern on the right, I think, are what I've heard a lot of discussion about here, what to do for patients who are pacemaker dependent. These are concerns, potentially contraindications, but in the real world, they're the issues that you face. Recent implants, imaging zones, epicardial leads, abandoned fractured leads, serial MRI and other implanted devices. So a regulatory perspective on what to do when you're uncertain or there's mixed systems. Again, that's outside of FDA's jurisdiction. FDA looks at the data that's submitted for a specific system under specific conditions and evaluates that. And that's what gets into the labeling for these devices. Physicians should treat their patients considering all the available evidence and the benefit risk for each individual patient with informed consent. And there are many resources available, great resource, the 2017 HRS Expert Consensus, referral to centers who have established protocols, the MagnaSafe Registry, which you heard about, and reference to a lot of other publications with important information that physicians can also reference. Specific to the 2017 HRS Consensus, which I saw was reaffirmed in 2022, it has really important recommendations for best practices, for repeat MR, new systems, monitoring, things like that, a really good flowchart for what to do for non-conditional MR systems with advice and recommendations, considerations for when you're replacing a system, and for the pediatric population. So that's a great resource. So in conclusion, the expectations at FDA for what testing is needed for MR conditional systems is well understood by manufacturers and is supported by guidance documents and standards. Almost all of the new systems are MR conditional when used according to their labeling and following the instruction during restrictions. It's always recommended to select a matching component if you're doing a replacement for IPG or LEADS. FDA doesn't really comment on the safety of MRI for non-MR conditional systems, mixed systems, abandoned LEADS, but they do respect the HRS and the recommendations in the clinical community for practice of medicine. So the consensus document is definitely a valuable resource that you can use, and I think the efforts that are underway are a good way to continue to discuss how to handle that in the big picture. Thank you. Thank you very much, Mark. You know, I think a common theme to these presentations, or at least a theme that came up a couple of times, is that a lot of the conditions that will make a system non-conditional are, you know, due to lack of data submitted to the FDA or theoretical risks and not based on actual demonstration of any harm in any patients. So that's, with that consideration, I'd like to introduce Dr. Chris Liu, who is going to help lead our panel discussion on what's next to facilitate CID patient access to MRI. All right, great. Thanks, Tim and Molly. So, you know, just to kind of help orient everyone here, so I'm finishing up my term as chair of the Health Policy and Regulatory Affairs Committee at HRS, and Molly and Tim are on this committee. And I've been fortunate to have had the chance to work with Rob and Martha and Tim on this call to action document and HRS. Actually, last year, we conducted a survey about this exact issue of HRS members and attendees of this very scientific sessions last year. And so that was published a few months ago. And so this is, of course, an issue that we all feel, you know, pretty passionate about. That's why, you know, we're here, and I'm sure that's why you're here. And it's really, you know, I think an issue that, of course, as our speakers have talked about, have, you know, involve multiple, involves multiple stakeholders. And I think that's really one of the challenges that has made this so difficult to really, you know, make progress because we're all thinking about the areas that we're, that we have expertise in. And yet, you know, a lot of the solutions that it really require really compromise. And it's then difficult for each of us to understand how much the other stakeholders could compromise. Right? And so certainly, you know, we welcome participation and questions and, you know, points from the audience. So, you know, I'll start just by kind of stirring the pot a little bit here. So, Mark, you know, you talked about, you know, we know, again, that you're not here speaking for the FDA. You know, you talked about sort of, you know, how MRI conditional labeling has changed over time. So, you know, for those of us who are electrophysiology practitioners, we remember when the first MRI conditional labeling was created, we had to do clinical studies, right, with the initial pacemakers and devices. And patients were scanned with MRI to demonstrate a safety or lack of events. And that's how MRI conditional labeling was, you know, was acquired. So over time then, the conditional labeling has evolved so that now it's mostly computational modeling, as you've shown. So why is it that that has not, you know, opened up this MRI conditional labeling to more situations like, you know, mixed vendor systems and, you know, abandoned leads and more situations so that we could, you know, expand the MRI conditional labeling? Okay. So FDA really just looks at the data that's submitted by industry for their specific application. And if a company elected to submit evidence, for example, for the safety of doing imaging with their systems with an abandoned lead, if they had that data, they could submit it and FDA would evaluate that. And if the data was acceptable for safety, then that could go in the label. And I think I heard that that had been done by at least one of the companies. So really, FDA, they just look at the data that's submitted and they evaluate it. And if it's acceptable, that goes into the labeling. So for mixed systems, again, they would have to evaluate and submit that, exactly how that would happen and whether they would cooperate to do that. I'm not sure. So it may be something that HRS could talk to the companies themselves. They have been known to cooperate in some cases when it's advantageous for everybody like the standard connectors for leads. So that might be an idea. So I have a question sort of the corollary. So does it have to be that the companies have to submit this? Because there's so much evidence it has to. It can't come from a different, it can't come from us, so to speak. Yeah. Let me. Go ahead. It's OK. So I want to remind everybody, there's never been a report in the English language literature ever of a patient that was appropriately screened and monitored who had an event, ever, ever, ever. So as we start to put hairs about the safety, we're, I think, getting to the point where a bigger risk is the patient who didn't have an MR as a result of our angst. Being a PI of a big study, you're the lightning rod of a lot of clinical information. Gentleman in his 70s with progressive paralysis and a brain scan that presumed CT that he had ALS. And finally got into MagnaSafe and a large tumor in their c-spine. And that was taken care of in a week, and he's walking around. And now that's one end of the spectrum. But there will be a day when there is a lawsuit, not because of a danger, but because somebody's exam was not performed and a diagnosis was missed or inappropriate therapy. Now, I want to underscore the fact that there is no data showing that abandoned leads are unsafe. I, when I sent the letter initially to Medicare, this is in 2017, the day that MagnaSafe was published. And I was expecting an extraordinarily slow bound process. I could not say enough good things about CMS. The coverage analysis group cannot say enough good things. The level of data analysis and what they provided to us. And they frankly came back and said, we can't do this, this, this, this. And we rebutted it all, and everything was approved except for one thing, abandoned leads. And why? Because there were only 40 cases. No one thought that it was a risk, but there were only 40 cases. So that's the only reason. We had a discussion at that level about six months ago, I think now, maybe a little bit longer. And the question is, when are they going to open up the NCD for change? So that's going to be for the purpose of getting another CED, coverage with evidence development, so that we can do more research. But of course, nothing is going to go quickly in today's environment. Not silly enough to think that kind of thing. But remember, this occurred not because industry, because industry doesn't really want to do that. It's because as investigators, we went to CMS and said, these things need to be covered. Not that FDA came back and said, it's frankly unsafe. Because that is a case of scientific whack-a-mole that you're never going to be able to solve. There's always going to be one more theoretical concern. So I apologize for running my mouth. I just had a question myself. I just had a question myself. So in normal times, when you said the FDA looked at the data, so in normal times, what is the time frame when you're handing your data and the FDA looks at it? Is it a month? Is it a year? And comes back with a decision. Do we know that? Well, for PMAs, those submissions would be 180 days for review. Yeah? You can ask Ms. Sheen. Sheen, right there. Go ahead. Again, with Mark, a former employee at FDA, now doing regulatory consulting. I want to underscore what Rob said. It's playing whack-a-mole. The problem with some of these large databases is that at the end of the day, you don't have a significant sample of systems match the leads with the can. I am also a participant in the standards community where we're looking at this with the exposure of MR to CIEDs, as well as the larger implantables. And what we learned through the course of the development of this standard is that it's a very complex problem. And it really does come down to an engineering and a definition of what is in the can and the lead that it's paired with. So while we have some very large and beautiful work by you guys with MagnaSafe and MagnaSafe2, there's not a statistically relevant sample to say that it's inappropriate or that it is appropriate. There's no risk associated with scanning a given pair. So to say that broadly, it's very hard to do. It would even be hard to do for an individual manufacturer to get that kind of data. Now, I want to also go back and talk in terms of the transition from. Before you run off, doesn't that mean, however, I don't mean anybody to clutch their scientific pearls for a second. If every single patient who has a Gen change will then theoretically go from conditional, non-conditional, and maybe fall off the radar as far as their access. I think with the stroke of a pen, even though it doesn't answer every single question, I think if it's an MR conditional lead system or Gen, then I think we can prove that with a one in a bazillion kind of risk that the risk is far outweighed because MR isn't done cosmetically. And I think that's a great point. But there's a very big difference between saying there was an absence of events seen in the course of the trial and saying that there's an absence of risk when you expose any combined system to an MR field. I understand that. But along those lines, FDA stands away. And again, I don't speak for the FDA any longer, as Mark does not. And I leave it to the agency to speak for themselves. But at the end of the day, FDA doesn't say you can't take a combined system, you can't take those patients through. They just say that, and there isn't an FDA term non-conditional, they just say that, doctor, if it is in your medical judgment that this is appropriate for the patient, and I think, and I would add, if you're taking appropriate steps, such as things that have been outlined by Dr. Halpern at Hopkins and some of the flow of taking care of these patients, looking at them before and after scanning, that you can safely scan those patients if the risk is acceptable. And that's a medical judgment or a medical decision. But when you turn and you want to have a manufacturer label that any combined components, it's safe to do under circumstances, FDA, if you're going to put it in the label, FDA looks at that. And they want to see the data that shows that there is a reasonable assurance of safety and effectiveness. And until we can aggregate that data, their hands are kind of tied in their ability to label it as such. Well, I mean, this actually makes me wonder, did we inadvertently then, with this whole MRI conditional labeling, actually create a problem where then we're essentially setting up sort of two class citizens, and where, as Rob essentially showed in the beginning, there is no such thing as MRI safe. And so MRI conditional does not mean MRI safe. Let me ask you a quick question. Is there a single scenario where you could not perform MRI? Do you know of any clinical scenario with a device today where you could not do MRI? So remember, this is not cosmetic. These people are in the scanner because brain, spine, something that's terrible. Yeah, so then it sort of begs the question of, should we, because the MRI conditional labeling then creates a situation where you have to prove, oh, OK, well, this is safe versus the other way around, where if you didn't have this kind of indication, then it could be assumed, OK, well, if you're going to have an MRI, there's some inherent risk associated with it. And if you're willing to accept the risk, take the precautions that are needed, then it can happen. And this then just sort of creates that extra burden of proof to achieve that. And then, of course, then someone has to then take on that work to then show that, oh, well, this situation is conditional. But then if you didn't evaluate that scenario, then that is not conditional. So we only have a few minutes left, and there's a variety of questions. And some of them I thought I could consolidate and just ask one of them, at least, from the audience, which is, how do we finance all of this? I think the question was sort of, who should finance the involvement of either the physician or the APP in supporting the scan? And what is the role of the device reps, which you had suggested there shouldn't be a role? So that's about four or five of the questions, if one of you guys don't mind answering that. Thoughts? Well, I guess if you ask the question, where's the money coming from? Then I would answer, I don't think you need to find the money. Because inherent in providing a clinical service, you can't say, well, we don't want to do a brain MRI, because I don't want to buy coil kind of thing, right? Same thing is true here. This has to be integrated into a service that everyone has available. The problem is that we've created this extraordinarily dense and multilayered physician and paraprofessional dense structure, where in reality, you only need a couple people, right? I'm sure there are many institutions where there's a nurse practitioner or PA or NP who shows up with the interrogator and does it all themselves. And whether or not they're probably not employed by radiology, but still it's the device clinic nurse or PA or whatever does it. So places that have a very slick program have long recognized that the access is our responsibility. As cardiologists, we have always taken care of everyone. We always take care of the patient, whereas the imagers don't. They're looking for an abnormality, a problem. But I think with a stroke of a pen, with some of the programs we've offered, we can give the radiology community cover. And also, there are new CPT codes that came out in 2025 to cover some of this work related to testing and programming around MRIs. And if you review the call to action statement that published today, we go into that in detail. I just wanted to add that from the colleagues that I asked if they could share their MRI protocols, it's pretty much what Dr. Russo says. You just provide the service. It's in the payment, the reimbursement for that MRI that actually covers the cost of that device nurse doing the service for the patient. So there are just many ways of just getting our patients to have what they need. And I agree. It just has to be a collaborative effort from all the parties involved. So just a couple of comments. I love this to talk about burden of proof, because we do have it backwards, right? That's like saying somebody is guilty before they're innocent. And we have to prove their innocence in a court of law. That's literally what we're doing. Can you imagine if the interventional cardiologist had to be there for stents that were implanted? Can you imagine? It would never happen. And we have literally done that to ourselves. So I agree with everything you guys are saying. And I love it, and I applaud it. But we have denied care for a theoretical risk with no evidence at all, ever, that we've ever had a problem. We have it completely backwards. We are taking the person and saying, you're in court, and you are guilty until proven innocent, instead of the other way around. And now we have years of data. And we have good data. And good things came out of 2017, because it's like the airlines, right? They find out that latch didn't work, and that led to a crash. We found out that read switches cannot be physical. We found out that we need to have shielding that's better and improved. And we have done that. Let me help you for a second. We have zero problems. I apologize. I apologize for that. Let me help you with, I have many friends in the radiology community. And when it is explained to them, using small words and speaking slowly, they do understand. And I think what you get back from people, from very smart radiologists, is that not only they're not cardiologists, they are uncomfortable with device, device programming, and the potential of these unknown complications, right? And if given the recommendations, our team is certified, we're going to operate by this particular guideline, it will remove all angst and levels of fear. So I think that's the way to get from the jailhouse to freedom. We're guilty and proven innocent. I love that word. That's exactly what it is. But everyone working on it, I say thank you, because, you know, so I'm from the University of Iowa. Just a little comment about it. We had an approved protocol, got a new MRI director, and they want to get rid of it. So we have meetings next month. So we've been doing it. We have one lady with a brain tumor. We've done 11 MRIs on her. It's been wonderful. And now they want us to stop it, so we can't see if it's growing or not. And, you know, it's that constant fight. So what you guys are doing. They were just talking about epicardioleads, if any of you guys wanted to talk about that. There's the world's expert right there, Dr. Lindsay Gackenheimer-Smith, who's going to come to the microphone in a second and address not only epicardiole but subcutaneous arrays. She's right behind you. Apologize. So regarding the evidence of epicardioleads, so it's relatively similar. There's not enough data. The patient population is small. My Y world in pediatric EP, over half of my patients have epicardioleads. They have epicardial pacemaker leads. They have epicardial ICD leads. And the largest study we have is a multi-center study that included, I think, almost 400 MRI scans, which is big news in our world. Nothing for adults. So it's going to take a lot to really get the numbers to really demonstrate what is needed for safety. So we're working on a lot of models and just having a conversation of what we can do from an epicardiolead perspective to kind of demonstrate safety to get more approval for that. So essentially, it comes down to we need more research. We need more advocacy for this patient population. And hopefully, with time, with all of this, we can get more headway and make approval for this. Thank you. And then go ahead. I'm from Canada, actually. And we've been doing MRIs for a while. We actually have a protocol with quite a few epicardioleads. Actually, one lady has had probably three MRIs already. She has an epicardiole. One issue we came up with, too, is the left bundle leads are unipolar, usually programmed unipolar. And it's important to know that you can't program unipolar with MRI, obviously, with the SureScan. And sometimes, the threshold could be high and bipolar. But as a single center, we've been doing it for a while. Is something like that can? And we have protocols. Our MRI department and pacemaker clinic work together. So we actually go there. And they get a nurse, an ACL nurse, to be there. But we go for the programming before and after. And our MP sets up the protocol. So it goes back and forth by email. So we have it set up pretty well for us. But is that information important to send for approval, to help with approving for FDA, for off-label? Because we do a lot of off-label. Great. Yeah, thank you. I mean, this is the sort of thing that a lot of institutions have figured out on their own. And it is a lot of collaboration, as you said. Well, wonderful. Well, I want to thank all our panelists for some wonderful talks and members of the audience for their contributions. And I think it's been a great session. Thank you.

MRI

cardiac implantable devices

lead heating

generator damage

radiology

off-label MRI

FDA approval

regulatory barriers

patient access

epicardial leads