How a Tiny Device Could Transform Fetal Surgery with Aimen Shaaban, MD

Erin Spain, MS: For pregnant people facing a complex fetal diagnosis, undergoing fetal surgery before giving birth isn't just a medical procedure. It can be a lifeline with the potential to greatly improve the outcome of a baby who is not developing as expected. But operating on a fetus in the womb presents unique challenges, particularly when it comes to keeping a constant watch on its health in real time. Today we are discussing a breakthrough that could help transform this field. A Northwestern medicine team has developed a first of its kind hair-like flexible device, designed for continuous real-time fetal monitoring during surgery. This innovation is the result of a collaboration between Northwestern University Bio Electronics pioneer, Dr. John Rogers, and our guest today, Dr. Aimen Shaaban Details on this technology were recently published in the journal Nature Biomedical Engineering. Joining us today is Dr. Shaaban. He is a professor of surgery and pediatrics at Northwestern University Feinberg School of Medicine, a fetal surgeon at Ann and Robert H. Lurie Children's Hospital of Chicago, and serves as the director of the Chicago Institute for Fetal Health. Welcome to the show. 

Aimen Shaaban, MD: Thank you very much, Erin. It's great to be here. 

Erin Spain, MS: Well, to start off, tell us about the Chicago Institute for Fetal Health. What is the work you and your team are doing there? And tell me about some of the families that you're caring for. 

Aimen Shaaban, MD: So at the Chicago Institute for Fetal Health, we are a multidisciplinary group of physicians, nurses and team members that evaluate and care for pregnancies that are complicated with abnormalities in the fetus. Virtually everywhere within the five or six state region, when a newborn diagnosis has been made about a complicated pregnancy we are the group that will be there to support and care for those mothers and that transition between her care as a pregnant patient and the baby's care as a newborn with developmental or congenital disease. This is an area where the lack of connectedness in our health system leads to challenges regarding the continuity and coordination of care. And there are occasions where the patient will even benefit from fetal surgery or surgery before birth to improve the outcome for the baby and that's a focus of our center as well. So that's what our center does comprehensively caring for moms with complicated pregnancies so they can get the best care from the time of diagnosis before birth, through the pregnancy, delivery, and care for the baby afterwards and the mom afterwards. 

Erin Spain, MS: How rare is an Institute like this in the Midwest and really around the country? 

Aimen Shaaban, MD: There are a handful of institutions with a similar capacity that we have within the United States. There are a number of other programs around the country that have a smaller sort of spectrum of care pathways for patients, something like fetal surgery, for example. There are some procedures we do that are minor procedures before birth that are done in a number of places, and some of the procedures that we do that are only done in a handful of centers around North America. 

Erin Spain, MS: Could you share some of the complications that you're trying to treat? Give me some examples. 

Aimen Shaaban, MD: Some of the more common cases that we will manage here with fetal surgery are things like, for example, spina bifida. Spina bifida is a condition where there's an opening in the spine in utero because the spine never closed. And the spinal cord is exposed to the outside and it leads to a number of neurologic complications for the baby. So spina bifida is a disease that can be treated before birth by doing the same operation we do after birth, but doing it before birth to cover and close the spinal canal to preserve the neurologic function for the baby. That's a big undertaking that requires a multidisciplinary team and a lot of experience and that's one of the things we do here. 

Erin Spain, MS: How early in pregnancy are you able to offer these life-changing procedures? 

Aimen Shaaban, MD: Some of the procedures we do are with minimally invasive surgery, laparoscopic or fetoscopic where we make a three millimeter incision in the skin and we're able to do it under a local anesthetic. Kind of like having your dentistry work done. And those procedures we can do typically as early as 15 or 16 weeks. Other procedures where we actually need to do a more open operation to make an incision and actually go inside the uterus with our instruments. Those need to be done a little bit later, at 23 or 24, 25 weeks. And some of the procedures are done simply with needles removing some fluid or other things that can be done even before 15 weeks gestation. 

Erin Spain, MS: These are some pretty incredible advances and you're able to do things you couldn't do 10 or 15 years ago, but you have noted that an area that is lacking is this real time monitoring of the fetus during a procedure that's sort of lagged behind some of these other advances. Can you tell me about that? What critical information about the fetus are you currently missing in the operating room, and what are the risks when that information gap exists? 

Aimen Shaaban, MD: When we do an operation, when we give anesthesia and other medications, we alter the normal physiology. And when we do that, we wanna make sure that the physiology is still supporting the basic needs of the patient. Here we have two patients. We have the mom and we have the baby. And we are monitoring the mom with her oxygen content and her blood, her heart rate, her temperature, respirations. We are monitoring her in several different ways with a high level of fidelity of accuracy so that we can ensure that she's stable and that when she wakes up from the operation, she's gonna be as good as she was when she went to sleep. But the baby, unfortunately, because the baby is not accessible, it's on the inside, and the more and more we do these things with minimally invasive surgery, the less opportunity we have to put something on the baby's finger or hand or back or anything. And we have to think about more creative ways. And right now what we do is something we've been doing for decades, which is simply monitoring the fetal heart rate pattern. Something that's typically done with a monitor on the outside of the mom's tummy. Every mom that's had a delivery understands what we're talking about. And we look at patterns and very frequently those patterns are irregular 'cause the baby is moving and there's other challenges in getting that information. Additionally, what we found with our approaches that the alterations in the heart rate are actually relatively late findings that we can actually see changes in oxygen level and in pH, extra carbon dioxide levels, lots of physiologic derangement that can occur and that the actual changes in the heart rate don't happen until very late. And so while we're monitoring with an ultrasound or what we call a fetal echocardiogram probe on the mom's tummy, we may be seeing things late. We really may not have a good handle on the baby's oxygen content in their blood, their pH, or their temperature; we don't have any estimate of that at all. So, what we need to do is do a better job monitoring the fetus and then we can expand and discover the strengths and weaknesses of that fetal echocardiographic monitoring and perhaps understand it better in how it predicts the normal and abnormal physiology. 

Erin Spain, MS: So you brought this problem to Bio Electronics pioneer Dr. John Rogers here at Northwestern. Tell me about this collaboration and how you presented this specific challenge to him and his team.  

Aimen Shaaban, MD: Dr. Rogers and his team are a really remarkable group of scientists. They're incredibly bright and innovative but they also are keen to understand the clinical problem and to address it. We spent a lot of time after the introductions, getting to know the problem and the constraints of being able to put monitors on the babies and the fetuses, and worked through that with some ideas on how that could be done during an operation but not interrupt the operation. So we looked through a whole variety of different things. We started out with the idea that we would do this using a wireless probe, something we could just kind of put under the skin for the baby or maybe drop it in the amniotic cavity or a variety of different things. And we could just use a sort of external wireless monitor, like a Bluetooth for example. And that proved to be quite challenging. And that's I think the next iteration, maybe we can come back to that at the end of this conversation. But we settled on the idea that because we have access to the uterus during these operations, we could slip a very small probe into the uterine cavity through one of these ports or adjacent to it. And that probe could then be put into the baby's bottom or esophagus or to the mouth or other areas to be able to monitor the fetus. And that would allow us to have direct wired access, which, to anyone who knows wireless, is always the faster and more reliable way to do it. But it had to be small. It had to meet the specs of the project and that took a number of iterations to get there. 

Erin Spain, MS: For people who maybe don't understand how interdisciplinary collaboration works at Northwestern, can you talk about how you approached Dr. Rogers on this? I mean, did you just call him up or email him, or how does something like this happen? 

Aimen Shaaban, MD: Dr. Rogers has a reputation for collaborating with the world. He's very accessible. He answers his phones and his emails promptly. And he spends a lot of time collaborating. So he knows the secrets, which is be available and be good at what you do. And he is both. So when I dropped him an email to perhaps pose the question to him about what we might want to do, he responded very quickly. We met face-to-face and we brought some of his team over to our center and got to know our program, but also then we took a deep dive into how we do surgery in the fetus so he could better understand the needs. 

Erin Spain, MS: So the result of this collaboration, as you mentioned, is this breakthrough device, and as you said, it's very tiny. It's like a hair-like flexible sensor. Is that right? 

Aimen Shaaban, MD: Yeah,I'm not sure if it's quite as small as a hair, but it's thin, very thin. It'd be maybe horse hair thin. It's a tiny little wire, basically, you can think of it. The wire itself communicates back and forth to a unit on the outside of the body. But on the inside of the body, there are sensors that detect oxygen levels in the blood, the pulse rate, can detect respirations and now can even detect the blood pressure in the fetus using a different type of analysis. And so that single tiny little probe, we insert it into the anus for the fetus just like we do with the temperature probes when they're in the ICU that allows us to then monitor the baby in the same way as we would, in some ways, the mother who's being monitored in a very complex way with multiple probes on the outside. 

 Erin Spain, MS: So seeing all those factors together now, how powerful is that for you as the surgeon? 

Aimen Shaaban, MD: Yeah, that's terrific. When I'm doing an operation, and these operations can take hours sometimes, we are doing the operation and being very careful to do a very difficult operation well, But a huge part of this is my concern for how well the baby is doing and understanding that sometimes things don't show up on our monitoring until the baby has progressed down a path quite far, and that these late findings can be pretty significant. Having that real time monitoring will make my life less stressful and that these babies are doing well. And if these babies aren't doing well, if there's a problem, well, we can address it right away without waiting minutes and minutes or longer for this to snowball and to become a really bad problem for the baby. That's sort of, in a selfish way, why I am very happy that we're heading in that direction with this technology, but even more so, our goal here is to make sure the baby is better after this operation. And having good monitoring and doing a stable, safe operation, that's critical. And we are using the state of the art and we have great success with that, but really we can do better and this is going to allow us to do better and perhaps even probe about whether what we were doing before, what we were actually seeing when the baby was perhaps not doing as well. We'll have a better understanding if we can for the first time ever ask complicated questions about fetal physiology during anesthesia, during surgery in a way that we could never do before. 

Erin Spain, MS: This just opens up so many new avenues and research for your team. I'm curious, so this has only been tested on animal models so far, is that right? 

Aimen Shaaban, MD: Yes, we are going to the process now of FDA approval and it will take some time for that, but that's our hope is the next step. 

Erin Spain, MS: Was there anything that surprised you during this process that you're already learning that you can share with us as you were doing the testing and investigating of this device? 

Aimen Shaaban, MD: I was surprised at the capabilities of this probe. Initially we thought if we could just monitor the oxygen content, just like when you get the red little sticker on your finger when you go to the hospital. They monitor your oxygen content. But if you could just do that it would be amazing to be able to do that. And then what I found is, oh no, we can do much more than that. And with innovation, creativity, with collaboration and some back and forth testing we really have developed a probe here that can do a whole lot and, actually can do more than the sensors that we do use currently for after birth. From a single probe, we can look at all these different parameters and actually not just look at the oxygen level on your finger, but we can actually look at the oxygen level in your organs, in your body, inside, which is a very difficult thing to get at. And we consider this sort of the first journey into core physiologic understanding during surgery. And perhaps what we see on a patient's finger doesn't necessarily reflect what's going on with the blood flow to their kidneys or their intestines, their liver, or their other vital organs. And we've seen changes in the way we do certain procedures or certain care in the ICU by other types of monitors that we use on the patient's body. But there's several complicated monitors that are out there. This one probe may be able to give us even better information than all those put together. If nothing else, we can compare them and use them as an adjunct to what we're doing now. So that has been a real exciting idea and unanticipated outcome that we're very excited about working on going forward as a whole. 

Erin Spain, MS: I'm gonna go back to something you mentioned earlier, which is a lot of Dr. Rogers devices are wireless. In this case we're talking about a wired device at this point in time, but do you see a possibility of this being wireless, especially if it could be used someday in the NICU on babies who are outside of the womb? 

Aimen Shaaban, MD: That's sort of the holy grail, is wireless devices, right? Anybody who's ever been in an ICU, and looks at the number of wires that are there and then you can imagine a baby that is no bigger than your hand with all these same devices and all the wires that, go along with that and these wires cannot be just cumbersome and problematic in that way, but they're also very stiff and unflexing. 'cause it can only be so small and they really don't fit right, they don't work well. And they seem to have the least reliability when you need it the most, when the baby's having a problem. So what we need is something that is small, that is wireless, ideally flexible and very reliable. The one thing I should probably mention about these probes. It is wireless in one way. So the wire goes from the inside, from the baby to the outside, but then there's a wireless sending device on the outside that then sends via Bluetooth to the receiving system that does the analysis. So, it is in some ways wireless from that part. But what we'd like is the whole wired part to be together and on the inside, so it's completely wireless on the outside. If we can achieve that sort of system, we could even potentially leave those probes in and continue to monitor the baby even when the mom goes home. And potentially have a situation where we inject it through a needle into a baby who is sick, and we do all the monitoring that currently requires for the baby to come into the hospital, to have the monitoring done in the third trimester.We could do that all at home. We could do it wirelessly and remotely and be able to access it via an app so that monitor can be done at home and it can be done perhaps with more than just monitoring the heart rate, we can monitor it in a much more sophisticated way, actually looking at oxygenation and temperature and all kinds of other things. And for a fetus who is sick, again, that is another window into the womb that allows us to see things that we've never seen before and be able to correlate that or compare that to what we've been doing for the last 50, 60 years. 

Erin Spain, MS: So you published about this in Nature Biomedical Engineering. What was the reaction from the community? 

Aimen Shaaban, MD: Terrific. I received lots and lots of emails and even direct good old fashioned letters asking about this and asking for more collaboration. And as we look towards the future, again, this is a project that came out of a collaborative effort and I think there are other collaborations that we can tend to engage and think even greater than what we've thought already. Because perhaps it's opened the door to think about what can be done as opposed to what we're stuck with. And that, to me, is very gratifying. So I hope that this transcends my career and goes on, and I hope that in the next decade we are doing things in a very different way with how we monitor, not just fetal surgery, but also pregnancies as a whole, and even extending into the newborn phases in the ICU and the operating room on small babies and maybe even older babies and adults because this technology it has scale to be able to expand this to all ages and all sizes. 

Erin Spain, MS: Why is this the type of research that really could only happen at Northwestern University? 

Aimen Shaaban, MD: Northwestern is a remarkable environment. This campus I walk around it all the time and I just marvel at the way we are allowed to bring together different disciplines and some of the greatest minds in the world to work together in very close proximity with a very open platform. It's an incubator for young and old minds as well to be able to think about better ways, better solutions. And of course I, my partners, my colleagues, my trainees as well as the patients benefit from this environment in a very remarkable way. 

Erin Spain, MS: What does this technology ultimately mean someday down the road for families who are facing complex fetal diagnosis? 

Aimen Shaaban, MD: I hope they see this as we're trying to do the best job we can to ensure that the outcome that they want, which is a healthy mom, a healthy baby and a healthy family, that we are working towards that goal and advancing our science and our understanding and our efforts along the same goal that they want. That we do as little as possible to disrupt the life and the health of the mom at the same time provide the greatest improvement and gains for that baby's chances for a successful outcome. 

Erin Spain, MS: What do you want people to know about this discovery? 

Aimen Shaaban, MD: I would like people to know that this was done out of a desire to provide better care and better quality for the care that we provide now, so that they know that we understand that there are limits to what we do today that we don't accept that. We don't accept those limits, that our goal is to push past those limits, to get to a better outcome, a better solution for all of their problems. This is another beginning, and I hope in 10 years that this is eclipsed. Perhaps this sparked some of those ideas from this idea that we can actually monitor the fetus in a way that we never have before. 

Erin Spain, MS: Do you think this is the end of your collaborations with Dr. Rogers? 

Aimen Shaaban, MD: I sure hope not.It's really been exciting and one of my favorite things in the world to do is to spend some time with his team and they have a good idea. Let's go try it. Let's make it even better and better. So this is I hope, just the beginning of a long term collaboration with one of the greatest scientists of our time. 

Erin Spain, MS: this idea of surgeon engineer collaboration. is still kind of new. Why would you encourage other folks to seek out these types of collaborations with Dr. Rogers or other engineers working in the biomedical space? 

Aimen Shaaban, MD: Two heads are always better than one. Several young, brilliant engineers working with a bunch of bright young surgical scientists and physician scientists. Really the sky's the limit here. There's very little that can't be solved here on this earth. Just a matter of. working together to figure it out. , artificial intelligence and other things that are coming online, it just boggles the mind how these things have advanced over the last few years. And if you don't embrace some of this technology and learn how to use it for good things. It's gonna pass us by and we owe it to ourselves and to our patients and to society to engage. So collaboration, working together with technology, with scientists that know how to use it responsibly. That is our goal and that's our responsibility. 

Erin Spain, MS: Final question. What could the timeline possibly look like from here on out to get this device into your operating room at the Chicago Institute for Fetal Health? 

Aimen Shaaban, MD: We are starting with the FDA. FDA has been working quite well with us to this point, and it requires clinical trials and probably some number of iterations on the prototypes to advance them towards clinical care. I imagine it will be not months but years, hopefully not more than a couple But we hope to have at least some approval and some direction later this year. 

Erin Spain, MS: We can't wait to have you back on the show after that takes place, and you can tell us all about how it's working for patients. 

Aimen Shaaban, MD: Thank you so much, Erin. 

Erin Spain, MS: Thanks for listening. Please click the bell to receive notifications about our latest episodes and follow us on social media @NUFeinbergMed to stay up to date with our latest research findings. 

Physicians who listen to this podcast may claim continuing medical education credit after listening to an episode of this program.

Target Audience

Academic/Research, Multiple specialties

Learning Objectives

At the conclusion of this activity, participants will be able to:

1. Identify the research interests and initiatives of Feinberg faculty.
2. Discuss new updates in clinical and translational research.

Accreditation Statement

The Northwestern University Feinberg School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Credit Designation Statement

The Northwestern University Feinberg School of Medicine designates this Enduring Material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

American Board of Surgery Continuous Certification Program

Successful completion of this CME activity enables the learner to earn credit toward the CME requirement(s) of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider's responsibility to submit learner completion information to ACCME for the purpose of granting ABS credit.

Disclosure Statement

Aimen Shaaban, MD, has nothing to disclose. Course director, Robert Rosa, MD, has nothing to disclose. Planning committee member, Erin Spain, has nothing to disclose. FSM’s CME Leadership, Review Committee, and Staff have no relevant financial relationships with ineligible companies to disclose.

All the relevant financial relationships for these individuals have been mitigated.