Diagnosic Imaging talks with Khan Siddiqui, M.D., chief medical officer and chief strategy officer of bedside MRI company, Hyperfine.
As the battle continues to rage against COVID-19 in hospitals nationwide, radiologists are expanding their equipment arsenal to pinpoint the growing list of complications that accompany the viral infection. Recently, greater attention has turned to the neurological problems that develop in some patients. To identify whether these patients -- many of whom are in medically-induced comas -- are experiencing clotting or hemorrhaging in the brain -- a small, but increasing, number of hospitals have turned to bedside MRI as another tool to help maximize patient care.
Diagnostic Imaging spoke with Khan Siddiqui, M.D., chief medical officer and chief strategy officer of bedside MRI company, Hyperfine. The company recently received U.S. Food & Drug Administration approval for providing in-room diagnosis of stroke. Here, Siddiqui discussed the role Hyperfine is being asked to play in the COVID-19 pandemic and the impact the technology is having on patient care and managment.
Diagnostic Imaging: How did Hyperfine come to play a direct role in patient management during the COVID-19 outbreak?
Siddiqui: The initial reach out really happened from people we had already talked to who were aware of the scanner – those we had talked to through conferences like the International Stroke Conference or the RSNA Conference. They were aware of our scanner’s existence, and they started realizing they don't have the ability to take their patients who are showing up with all these neurological symptoms to get imaging done.
The big change happened when the Henry Ford Health System folks published a paper on neurological findings on March 31. That's when, suddenly, people realized all these patients on ventilators who are not waking up may not be due to respiratory stuff. Maybe something else is going on. Then, the papers started coming about cardiac-related conditions and kidney issues. Suddenly, the awareness for brain immediately started. That's when we got a call from Dr. Michael Schulder at Northwell Health. He said he had so many patients that are not waking up who also presented neurological symptoms. The initial thought process was that the patients coming in are having strokes, but they are also COVID positive. Maybe the two were related. That's what the thought process was.
Then, it evolved into thinking that maybe the virus is causing these issues. It's not that the patient has another disease and is COVID positive, but they started realizing that this may be all be caused by COVID. And, they started getting patients who did not have respiratory disease, but had brain things. They would test positive because the hospital was doing a global test on everybody showing up. Suddenly, they realized that all these patients sitting in the ICU because of brain issues, not breathing issues, also are COVID positive. Then, the disease started acting differently. Dr. Schulder and the teams have practiced for decades. They see stroke patients every single day. They see hemorrhage patients every single day. They called me, and said their patients are not behaving the way typical patient does, meaning this has to be something different. Then, papers come out that say it's more of a hypercoagulable problem, so they see pulmonary embolism in lungs and things like that. But, they're seeing bleeds in the head which is completely opposite.
So, that's how the whole thing started. Initially, that paper came out. And, initially the folks that were aware of us start reaching out, then people got a broader awareness, and they started to reach out to us. And, I'm trying to catch up in getting scanners manufactured as fast as we can to start delivering these as fast as we can.
Diagnostic Imaging: How many institutions are using Hyperfine now?
Siddiqui: There are a total of seven sites deployed with nine scanners, but two of them are actually using it for COVID patients right now.
Diagnostic Imaging: Turning specifically to these patients, what have providers who are using Hyperfine with COVID-19-positive patients told you about how they’re using it and the results they’re seeing?
Siddiqui: I think they've scanned by now two dozen or so patients on the scanner in both sites combined. The main reason has been that all the ventilators in the hospital are completely taken up, even the transport ventilator that you would typically use to take the patient down to MRI is also being used to treat somebody else. To move the patient now you need to do manual bagging, and when you're doing bagging, you're putting everybody at risk because all this air is coming out from the patient. Plus, the nurse was going with them. They also in short supply. They’re taking care of four or five patient at the same time. So, when one nurse goes, somebody else has to take care of their five patients. Just logistically, it's a nightmare to do this whole thing.
And, in the case of Dr. Schulder at Northwell Health, because they are so inundated with COVID-19 with almost 80 percent of the patients the hospital being COVID-positive, they have multiple units where they have COVID-positive patients intubated on right now. So, they don't have just one place. For our scanner, they still drive it around for one unit to scan some patients. Then, they take it to the elevator, go to the next level, scan more people. They've been doing that, and it’s been very helpful for them. They are going to publish all the findings of doing it. I don't know have exact details on what exact diagnoses has happened. But, I've heard from them that in almost half the patients, they found findings and in about one third of them, they've changed management because of what they saw.
Diagnostic Imaging: When it comes to using the system itself, what kind of findings is Hyperfine capable of identifying in these patients, specifically related to COVID-19 or in general.
Siddiqui: Hyperfine can do anything that typical MRI would do. We struggle with smaller millimeter-level findings, so that’s something probably we're not able to do. But, most of the findings we’re able to do because anything that you can use T1 or T2 weighted images, FLAIR and diffusion weighted imaging for, those are all possible to do. So, it's going to be hemorrhage, stroke, any kind of mass effects or tumor, things like that you should be able to see it on the scanner.
Diagnostic Imaging: When it comes to the impact, what does the rapid nature of these results do for the ability to provide care?
Siddiqui: A typical COVID patient that is coming in with respiratory symptoms, you don't really worry about their bleeding status or clotting status. But, if you see stroke or bleed in the head, that completely changes the whole picture. Now, they need to be on management for blood clots if there are clots present. If they're bleeding, you need to make sure they're not bleeding too much and continually monitor if they're causing any pressure on certain part of the brain. If there's anything that needs to be surgically removed, then you must be able to identify that quickly. So, that completely changes your typical management that you would do with a patient on a ventilator. These patients are all sedated. So, you can't assess their neurological symptoms. This is the only way to be able to actually see what is going on.
Diagnostic Imaging: In addition to those benefits of bedside MRI, what are the benefits that Hyperfine is providing in making sure people are able to abide by the safety protocols that are in place for controlling viral transmission?
Siddiqui: Our scanners have gone through the safety, infection control, biocompatibility testing – all of those things. It's very easy to clean. Use a typical Sani-wipe to just wipe down surfaces. They are pretty straight surfaces. One of the biggest benefits of the scanner is that it can be an environment that is electronically noisy. Typically, you can’t have a ventilator running, EKG monitors running, ECMO machines, and all the infusion pumps running all the time because all those electronics are sensitive to MR. And, MRs are sensitive to the noise coming from them. That's the big innovation in our science. We completely cancel out all that noise. And, with Hyperfine with what is called the 5 Gauss line -- within two-and-a-half-feet of the center of the scanner – there’s no risk of projectile metals either. So, if a patient has a passive metal that doesn't have electronics, there is no risk of it moving even in an acute state. Those are the benefits that you just don't see. I mean nobody does MRI imaging on a patient on ECMO just because of that reason. And, here, we can possibly do that.
Diagnostic Imaging: Are there any words of guidance that you can give to focus on what providers can anticipate that Hyperfine will be able to do – things that can be kept in the back of their mind so they're using it within the intended parameters?
Siddiqui: Absolutely. It’s very, very early. These are things we've never seen before because not many sites have it yet. And, we've not scanned that many patients. We think we can scan pretty much everything that is out there based on the sequences that we are releasing. That's what our FDA approval is on also. I think the guidance is going to be that there's a clinical need to do an image, and there's risk of patient transportation or the lack of availability to be able to use conventional scanners, as well as time, complexity, and other things.
This becomes a very easy, affordable technology to be able to understand what is happening, not only to primarily diagnose the patient, but also to be used in a triage scenario. For example, do we need to do 3T imaging on this patient or not, can we get guidance on what is going on with the patient? The guidance is really based on clinical judgement. If you need MRI imaging, I always tell my clinicians, as the radiologist, “Ask me the clinical question you want answered, and let us tell you what image technology is best.” Do you need a CT? Do you need an MR? And, if you need an MR, then you decide if the patient is high risk so they can't be moved to MR scanner. If that's the case, then use the Hyperfine MR scanner. It’s easy to move. I have some sites calling that have an MRI scanner inside the ICU only 100 feet away from the patient, but their nurses are uncomfortable moving the patient. With all these machines, all the equipment, everybody's being extra cautious. How do you safely move a patient 100 feet? There are other patients in the corridor or other people around that all will get exposed because you can't control the environment when the patient is moving.
This was this issue for Dr. Schulder at Northwell. Multiple hospital floors now have become ICUs. Even though scanners are on one floor with the neuro ICU, they're not on the floor above or below that have also been converted to ICUs. So, how do you move those patients? It becomes challenging when a site gets saturated with a number of patients intubated, and they're trying to figure out how to best manage them when they're not weaning off the ventilator or they’re presenting neurological symptoms. That's where the Hyperfine application comes in.
Just a few days ago, I got a call from another academic institution. They have patients that did not show up with respiratory symptoms, some as young as 28 years old and as old as 101. They primarily showed up for neurological symptoms, and they're not behaving the right way. They've done CT scans. They have portable CT, but it doesn't show anything. They want to get an MRI done, and they have 20 MRI scanners, but the risk is just too high to move the patient for the MRI. And, CT is not showing anything else. They need a scanner.
I'm seeing those stories where before COVID, it was like, “We have enough scanners. We don't need to worry. We have a program in place to do this stuff.” But now, suddenly, there's no ventilator to transport the patient. It’s just too risky. There's no one to go take a patient for two hours for an MRI scan. It just becomes a much more intense situation now.
Diagnostic Imaging: What do you hope the overall impact of Hyperfine and bedside MRI will be when it comes to the ability to provide the highest level of patient care that we can right now as we continue to go through this outbreak?
Siddiqui: I hope we are saving lives. At the end of the day, it's all about the patient. I hope we can quickly identify issues happening with a patient and appropriately help guide the management the right way. And, then, if you're able to do that in this situation, that's a win for us. The mission that we started with to make imaging accessible to anybody in any place is fulfilled. That's what the dream is. That's what the team has worked on for six years now to build this technology. If we’re able to make that impact, and we save a patient’s life, that’s what we care about the end of the day.