In this feature interview, EP Lab Digest speaks with Steve Wedan, CEO of Imricor Medical Systems, and Dr. Philipp Fischer, Head of Cardiology at Siemens Healthineers, about the companies’ new partnership to develop an integrated solution that combines the clinical benefits of real-time MRI scans with 3D-guided cardiac ablation.
Tell us more about this new partnership between Imricor and Siemens. How did it come about?
Wedan: We have worked toward the same goals in MR-guided EP for years. Now that the devices and software systems are becoming mature, we are working together to develop solutions that are fully integrated. Therefore, it was a natural coming together for us.
Fischer: Both companies have been working together on research projects for several years, where we were able to demonstrate exciting benefits of MR-guided EP ablation in a pre-clinical setting. Now it’s time to start productizing the cutting-edge technologies of the two companies into one integrated innovative EP treatment solution. With Siemens’ decade-long history of market-leading cardiac MRI technologies and Imricor’s strong history of building MR-compatible devices, we are well prepared to revolutionize interventional procedures in EP.
What can you tell us about the integrated approach being developed combining MRI-compatible devices from Imricor with Siemens’ interventional CMR (iCMR) EP labs?
Wedan: The concept of doing MRI-guided ablation procedures is not a new idea. MRI promises more effective, faster, safer, and less expensive treatment for arrhythmia patients. That is especially true for complex ablation procedures such as for treating atrial fibrillation (AF) or ventricular tachycardia (VT), and we’re finding now that it is also true for relatively simple ablation procedures such as for treating atrial flutter. In the past, the thought was that there would be little motivation to perform atrial flutter ablations guided by MRI, because these procedures were already successful and relatively simple. However, we are finding that these procedures can be performed with our devices in the MRI lab in the same amount of time, with the same effectiveness, and for the same cost, with the added benefit of a radiation-free setting. There is really no downside to doing ablations in the MRI lab.
In what ways could this integrated solution help patients and physicians?
Wedan: It is really about improved outcomes. The driving force for choosing MRI is to give the doctor back his or her vision. Through the MRI images, doctors can see not only the tissue they’re working on, but also the characteristics of the tissue they’re working on. This allows them to do several things. First, they can assess the cardiac substrate prior to an ablation procedure, allowing them to plan an individualized treatment strategy for each patient. In addition, they can more precisely track and locate our catheter with Active MR Tracking, which is automatically calibrated and registered to the MRI images. Finally, MRI offers a procedural endpoint that they can actually see. Doctors currently use electrical isolation as the endpoint for all ablation procedures. The trouble is that it is impossible, today, to determine which ablation lesions are permanent and which are temporary. With MRI, doctors can augment the electrical conduction block with a visual indication of which burns have formed durable lesions and which have resulted in only temporary injury. In the MRI lab, they can fill gaps in their ablation lines and avoid the need for repeat procedures. In short, they can see what they’re doing and they can see what they’ve done.
What are the benefits of Siemens’ interventional CMR EP lab technology?
Fischer: There are benefits for operators, healthcare and hospital settings, and patients. For the operators, one clear benefit is that because MRI technology provides a non-radiating interventional environment, there are no associated health risks. The second benefit is the additional information input by cardiac MRI that, so far, has only been used separately on the diagnostic side. Information such as scar burden and morphology, function, and additional tissue and lesion characteristics is now being made available within the intervention itself, which can help operators make better treatment decisions and guide the ablation procedure. For hospitals, MRI technology could reduce the number of patients who need repeat ablations. With conventional ablation, up to 50% of patients come back for not only a second treatment, but sometimes a third or fourth treatment. This leads to high resource utilization and limits hospitals from providing better outcomes for more patients. Our partnership with Imricor will help to define the true benefits and potential of interventional CMR. More personalized and precise procedures will be the basis for increased long-term treatment success and patient outcomes.
Describe the iCMR technology.
Fischer: The plan is on the one hand to take the state-of-the-art tools and workflows known and appreciated by EP physicians in the EP lab, transfer these into an MRI EP lab, and — by doing this — make the benefits of MRI available during the procedure. Many advanced cardiac MR imaging technologies we know from diagnostic imaging will become available during EP treatments. Siemens has developed a number of cutting-edge cardiac MRI technologies in recent years, such as Compressed Sensing for shortened exam times or our Cardiac Dot engine for automated workflows during the exam. On the other hand, we have a clear plan to provide all important EP features, including reliable recording of intracardiac electrical signals, electroanatomic mapping, and active catheter tracking in a dedicated application software for EP procedure guidance tailored to the specific needs and prospects of iCMR. Real-time catheter tracking and guidance is one of the core fields we are closely developing with our collaboration partner, Imricor. The software will also add more relevant information to guide therapy, including scar distribution and ablation lesion formation in the heart. This will support electrophysiologists to design individualized ablation strategies for each patient. With all these features combined, we are confident we can provide a treatment platform that supports better EP treatment outcomes as compared to today’s standard of care.
Tell us about Imricor’s MR-enabled devices for EP: the Advantage-MR™ EP Recorder/Stimulator System and the Vision-MR™ Ablation Catheter.
Wedan: We set out to develop a solution for MRI-guided EP that provides an environment and tools that are as similar as possible to the existing tools doctors are familiar with. We want doctors to move from their old labs into what I consider 21st century MRI labs with as much ease as possible. Therefore, we designed our Advantage-MR EP Recorder/Simulator such that it delivers cardiac signal fidelity and stimulation functionality that are as good or better than anything currently available. Also, our Vision-MR Ablation Catheter has been designed to look, feel, and function like other conventional ablation catheters. The truth is that delivering all of this for the MRI environment was not easy, but the work is behind us and we look forward to a new standard of care for EP, where doctors have the advanced imaging and visualization tools that I think patients expect they would have in 2017.
Tell us about the live case of MRI-guided ablation, shown live for the first time at EHRA 2017.
Wedan: It was very special for us to publically display, for the first time, a clinical procedure with our devices and systems after 10 years of development. The case was an atrial flutter ablation performed by Dr. Philipp Sommer at the Helios Heart Center in Leipzig, Germany. While I watched from the audience in Vienna, I could hear people around me whispering “amazing” and “wow!” We’ve been at this awhile, so it can be easy for us sometimes to lose sight of how groundbreaking this work is. That live case was a good reminder.
What centers are currently evaluating this real-time MRI-guided cardiac ablation approach in an interventional MRI suite?
Wedan: There are many sites in Europe, including the Leipzig Heart Center, King’s College London, Dresden Heart Center, and CHU de Bordeaux. There are also sites in the U.S. such as Johns Hopkins, NIH, University of Utah, and the University of Pennsylvania. In addition, Royal Adelaide Hospital in Australia will be an early clinical site. It is exciting that the number of sites looking into installing dedicated MRI EP labs is growing all the time. That growth is something that we’re working closely on with Siemens. It is important that we help clinicians and hospitals plan today for the MRI lab that they want installed in 1-2 years.
Is an MR-guided ablation solution also cost effective?
Wedan: That’s a great question. People are usually surprised that an MRI EP lab costs about the same as a biplane fluoroscopy EP lab. However, once installed, one of the benefits of an MRI EP lab is that it can also be used for diagnostic imaging when ablations aren’t being performed. This can generate additional revenue for the hospital, compared to a vacant and idle x-ray EP lab. When it comes to the disposable costs associated with MRI-guided ablations, we’ve succeeded in making our devices both MR compatible and also cost about the same as conventional EP catheters that exist today. Finally, when comparing the cost of doing ablations guided by MRI, it’s important to consider the effectiveness of the procedure. If you can do a better job in the MRI lab, and you decrease the number of repeat procedures needed, then the cost per patient goes down and everyone wins.
What is the timeframe for development of this integrated solution?
Fischer: In the next years, we will further develop our combined iCMR-EP solution and, in collaboration with leading electrophysiologists worldwide, generate clinical evidence for indications such as ventricular tachycardia. In a first phase, we aim to achieve decisive results in terms of efficacy and safety of the procedures. In this phase, we also target for regulatory approval by European and U.S. authorities. We will then enter the second phase, which will be about introducing the technology to a broader EP community. We estimate that in a few years from now, a considerable number of advanced EP institutions will adopt the iCMR-EP approach.
Wedan: Our Advantage-MR EP Recorder/Stimulator system is already CE approved, and we’re currently conducting the clinical trial for the Vision-MR Ablation Catheter, which we expect to receive CE mark on in the second quarter of next year. We have other devices in our pipeline that will follow very quickly in 2018; devices such as diagnostic catheters, sheaths, and transseptal puncture kits will round out the tools that doctors need to perform procedures, especially complex ablations. We’re starting on our FDA approval as well, and plan to bring this technology to the U.S. as quickly as we can.
How does an approach using interventional MRI for electrophysiology compare to other imaging modalities? Why is this important?
Fischer: First of all, it is important to state that in the past decade, we have made significant progress in fluoroscopy-based EP procedures — for example, with ultra low-dose technology and advanced mapping system integration — and we will continue our efforts in this field. In addition to current state-of-the-art technologies, electrophysiologists are always looking for imaging information beyond x-ray to better identify the correct patient population, plan their procedures, and stratify risks. Why? They don’t get critical pathological information from an image because there is no relevant soft tissue contrast. Also, despite the capability to combine mapping functionality with pre-acquired CT and MR images, there is still a lack of information for treatment guidance that contributes to the not yet entirely satisfying outcomes of complex ablation procedures. More aspects have to be considered to gain insight into the individual pathophysiology of arrhythmias and to create more personalized treatment approaches. A lot of work is being done by clinical collaborators who have analyzed the relation of fibrosis in the atrium to procedure success. There are other investigators researching the same for scar burden in the ventricle. Researchers already published exciting first results on temperature mapping during MRI-guided ablation, which allows for real-time treatment control of the energy deployed in the tissue to not only monitor ablation lesion formation but also avoid harming neighboring tissue like the esophagus or other sensible structures. In summary, there is far more to see in the heart with advanced soft tissue imaging, and MR is the preferred modality to assess tissue types, distribution, and patterns during the diagnostic and therapeutic parts of the procedure.
Why is real-time MRI guided ablation an exciting potential new option for treating complex cardiac arrhythmias?
Wedan: In my opinion, nothing compares to cardiac MR for EP. To be able to see tissue, individualize the treatment strategies, and provide visual therapy endpoints of durable lesions are abilities that only MRI can deliver — no other imaging modality can do that. What I’m most excited about in making this shift is taking the same procedure, with devices and electrical tools that doctors are familiar with, and moving it into an MRI environment where all we do is augment what they’re already doing. We don’t take anything away, and instead we give them this exquisite MRI imaging. I think this will set a new baseline for innovation. We’ve seen ablation procedures mature over the past 20 years, and it seems we’ve come upon the limits of what we’re able to do in an environment. I expect that shifting over into an MRI environment will set a new baseline platform from which the next 20 years of innovation will begin.
Is there anything else you’d like to add?
Fischer: As Steve Wedan mentioned, we are right now at the beginning of an exciting era of interventional procedures under real-time MRI guidance. There are good reasons that this area will not be limited to EP procedures, but extend to other cardiac interventions such as structural heart or even beyond into interventional oncology, neurovascular interventions, or minimal invasive surgery. We believe these disciplines will benefit from intra-procedural soft tissue imaging as much as EP will.