麻豆传媒

What: Live, virtual press briefing with Mercy Medical Center surgeon Dr. Gregory Gasbarro, to discuss the advanced new surgical technique using mixed reality to assist in the operating room.

Who: Gregory Gasbarro, MD
Shoulder Fellowship-trained orthopedic surgeon at The Shoulder, Elbow, Wrist and Hand Center at Mercy and the Medical Director of the Shoulder Joint Journey program

When: July 2, 2024, 11:00 AM ET

Where: 麻豆传媒 Live Zoom Room (address will be included in follow-up email)

Reporters: if you cannot attend at the time of the event, but you would like to receive the video and transcript afterwards, please register to be added to the list and we will send you those materials as soon as they are available. 

TRANSCRIPT:

News: Hello and welcome to this 麻豆传媒 live expert Q and A. We have with us. Dr Gasbarro from Mercy Medical Center. Dr Gasbarro, please feel free to go ahead and introduce yourself and tell us about this new surgical technique and technology that you've been working with. 

Gasbarro: Sure. Well, I'm a shoulder fellowship trained orthopedic surgeon at Mercy Medical Center in Baltimore, Maryland. I'm in charge of what's called our Shoulder Joint Journey program, which is a perioperative education program around shoulder replacement surgery. It allows us to provide education to the patients before, during and after their procedure. As you may see from this presentation, shoulder replacement surgery and shoulder care in general is my passion, and I hope that shines through. 

By way of background, as you look at the digital technology we all have now, enabling technologies are a big spend and a big part of the market share in orthopedics globally. So in 2022 this study was done and looking at digital it's a $58 billion market, and about 2.1% of that is spent on what I'm going to be sort of explaining to you, which is a small piece of everything. When you look at shoulder replacement, maybe 20 or 30 years ago, many of the surgeons were getting X rays and using that as a way of figuring out what the problem was and how they were going to fix it in the operating room. So it's very qualitative, and you're really just sort of eyeballing things. Over time, CT scans became more commonplace for planning. It gives a three dimensional model of the shoulder and allows you to look at anatomy in a different way. And as that has progressed into the late 2000s and early 2010s, those CT scans were then translated into software that companies had developed in order to get into a virtual planning environment. So you could look in three dimensions at a patient's anatomy, and then, within this planning environment, you could position the implants and size the implants to the patients. 

So that's sort of where we've been, in the 2010s and now, as we're evolving into the 2020s, for about 10 plus years now, patient specific instrumentation has been around. Basically from that virtual plan, a guide is created, and it fits into each individual patient, and it positions you, particularly on the socket side, in order to do all the work that you need to do to position the implant in the correct way. But as we've evolved now from patient specific instrumentation to this new realm of mixed reality, that 3D plan in the software program can now be uploaded into a set of goggles and projected via holograms in the real world. So that's what I'm going to get into with mixed reality navigation, and it's just making us much more accurate in the operating room and doing what we're doing. 

Shoulder replacements are done for two main reasons. One is osteoarthritis of the glenohumeral joint, or the shoulder joint. So if patients lose the shiny surfaces on the ends of the bone called cartilage, they may need a shoulder replacement surgery in order to reconstruct the joint. There's two types, an anatomic shoulder replacement, which replaces the ball with a ball and the socket with a socket which is usually plastic. And another type of replacement, which is called a reverse shoulder replacement, where you replace the socket with the ball and the ball with a socket, and you flip the joint over, and that's more commonly done in patients for the other reason to have a shoulder replacement, which is a chronic rotator cuff tear, which doesn't allow patients to stabilize the ball centrally on their joint, and the ball rises up in the joint and creates problems. 

So here's what a software program for virtual planning might look like. So on the left, or an example of an anatomic on the right, an example of a reverse. Here’s an example of the 3d planning environment within the virtual software that we use. So within this you can position the implant to the patient. You can size it to the patient. You can determine how much bone you want to take away. You can rotate things. You can measure the sizes of the screws that you're going to use. So everything you can imagine during the surgery you may want to execute, you can execute prior to the surgery and hopefully make your errors there, rather than in the patient.

As you look at virtual reality, some people ask, well, what is mixed reality? Well, reality is what we're living in. Virtual reality would be like a video game from the 80s or 90s. You're fully immersed into a non-real environment, and then the overlay between the two is mixed reality, which you can see nicely in these pictures. And when we're using this in the operating room, you basically can take that 3D plan from the virtual software program, upload it into the goggles and overlay these projections, which are holograms, on to the field, which you can interact with, both with voice and with gesture commands. So there's haptics involved. And it can really reference you during the surgery to the operative field. And it can tell you exactly where you need to put the pin to do all the glenoid work that you need to do, which is on the socket side. 

So you know, why is this important? Well, it has a major potential reducer learning curve. So if you take a surgeon that does 10 shoulder replacements a year, and isn't, used to doing this at a high volume, if they have a plan that's in place before the surgery, and then they have a guide with them, which is basically the goggles that is taking them through the operation, they may be able to execute it a lot better, and maybe the outcome of the patient will be a lot better. It's also going to give us a lot of data to inform best practices. It’s going to help with acquiring skill and for lower volume surgeons, hopefully reducing cost and then avoiding errors. 

When we look at the outcomes of patients, where you put that socket side is so important for the durability, for the ultimate range of motion, and ultimately, how happy patients are after the surgery with their outcome. So when we eyeball things in the operating room, this is a deep dissection into the shoulder joint from an angle that's not directly onto the socket, and also the scapula, which is where the socket sits. It can move in the space based on how the patient's sitting, based on the anatomy of their spine. So you can get really fooled sometimes where you are and our inherent error and how we place our glenoid pin, which guides us how to put these implants in from the front to the back of us into the top and to the bottom of us can be off by about 10 or 15 degrees. With patient specific instrumentation that decreases our error to about three to four degrees. But there are some limitations there, because these have to be placed on a sort of a long guide into the joint. It has to fit very nicely on to the patient's socket, and you can still be off just a little bit. And we also have to wait for the guides. There's about two or three weeks of lead time for the guides to be ordered and then fabricated and sterilized. So, with mixed reality, we're now able to take that three dimensional plan; I can plan it a day or two ahead of time with no lead time, and it allows me to interact with this 3D data from our virtual plan in real time during the operation. It's FDA approved for entry of that glenoid pin within two millimeters of the plan site, and also within two degrees of our top to bottom and our front to back accuracy and how we put these in. 

This is an example, the first case that we did a few weeks ago. You can see the goggles I'm wearing there. It's a Microsoft HoloLens two. And then you can see the projection onto the surgical field there of where that pin and that green laser line is going to be, and it's telling me some data up above there of where I am and how I'm positioned according to my plan. So that's just sort of a fast, general overview. I'm going to stop sharing my screen now, and if any of that was unclear, please ask questions and we'll sort it out.

News: Yeah, great. Thank you. Dr Gasbarro, just a few questions to help get things started. And members of the media, please, you're very welcome to ask questions of your own. Please chat them, and I'll go ahead and ask them to Dr Gasbarro, for you. Dr. Gasbarro, I'm going to share a quick video animation of part of this, and I would like to ask you if you can tell what this is like from the surgeon's perspective. This guidance that the tool is providing in this example, what's that like for you as the surgeon?

Gasbarro: Well, you know, it's really nice at this stage, it's all voice commands. So at this stage, you've already registered the patient's anatomy, and you're basically referencing that to your preoperative plan. So as you're making these subtle movements in the shoulder, you're seeing in real time, those gauges adjust. So your inclination, top to bottom, your version front to back, and also your entry site. And it just gives you confidence during the surgery that you're actually executing the plan that you've created, which ultimately should hopefully improve the patient's outcomes, but that's yet to be determined.

News: A question from Valerie Hahn with the Catholic Health Association, at what point in the surgery do you wear the goggles? Just when you have to be extra precise and positioning?

Gasbarro: So I make my normal dissection like I normally would, and then, up until about a month ago, I was using patient specific instrumentation, where I would take a printed guide to the patient, place it in, and then put the pin down the guide to put me in the right position. So at the point where I used to grab the guide, is now when I have one of the assistants put the goggles on, and I have to register the patient's anatomy through a workflow and then execute that pin entry. And on average, so far, it's taken me about 11 minutes of operative time to do that. We’ve done five cases now. And I think with more experience, as we work on this technology, I think it's only going to be adding a couple minutes to our cases. 

News: Tell us a little bit about that pre-op planning and the information that you're feeding into the software to get this guide. How does that work? And what are some of the elements involved in that, that people could be familiar with. Are these certain types of scans that are done to the patient's body, and how does that work? 

Gasbarro: So it depends on the company that you're working with, but you order a CT scan and it has to be done in a specific way in order to upload it into each individual company's software. So for Stryker Blueprint, you have to have a particular protocol that you provide to the patient to give to the radiology tech; once that is placed into the software program, your model is then reconstructed from the CT scan of the patient's anatomy, and the critical information that's being given is how much of the socket has been worn away. What position is the socket placed in relative to columns of bone that the scapula has that are more robust. So, is the socket really worn out more to the back? Is it worn out more to the top? Having all this information allows you to plan it, to recreate what that pre- morbid or pre-arthritic condition might have been, in order to optimize the position of the implants, and how the implants are positioned relative to one another is critically important for the stability of the implant as well. So all these different inputs of how bad the deformity is before the surgery and then recreating after the surgery a stable environment that's going to be durable and hopefully last the patient 20 or 30 or more years, all have an effect on the outcome. And I think preoperative planning is something that every shoulder surgeon should be in 2024 doing.

News: And compare that, if you would, to before this technology, you'd be basing your judgment about what's needed based on less advanced technology. So tell us a little bit what that leap is like from looking at X rays or CT versus this new kind of 3D modeling as well as the lens projection while you're doing it.

Gasbarro: Well, one thing to remember is someone that's been in practice now for five years and around orthopedics for 11 years, I've sort of grown into this field with all these digital tools. So at no point in my training were my mentors just looking at x- rays before their shoulder replacements; preoperative planning had already been a part of the regular practice of the people who trained me. For physicians before that, I would imagine if you only had an X-ray, it really sets you up for errors within the OR and it doesn't allow you to position the implants in the way that you necessarily may have wanted to, to make them stable, and it led to downstream effects. 

With anatomic shoulder replacements, the way you put the piece of plastic on to the socket really has an effect on its longevity. So it can lead to early glenoid failure if it's placed incorrectly. There's other factors that have led to anatomic shoulder replacements failing. And then, in the reverse, the way you put the base plate in, which is what the ball sits on, many things were learned from, prior to planning, where these base plates were placed, they were placed sometimes too high. They have to be really low. They've got to be pointed neutral with the axis of the scapula are a little bit inferiorly inclined in order to avoid when the tray rotates around, hitting the scapular pillar. Other factors, too, are, building away from the glenoid with either metal or with bone in order to avoid that tray from what's called notching on to the scapular pillar, which could lead to early failure; it could lead to dislocation. So all these things prior to 3D planning, I think, were things that surgeons were sort of like I said, eyeballing intraoperatively and hoping they created a stable environment that was going to be long lasting. But I think these new tools allow us to more confidently tell patients that this is something that could be a solution for you for hopefully, the rest of your life. 

News: Follow up question from Valerie, you said that you had performed five of these surgeries so far. When was the first one and when was the last one? And do you have any planned for the future, and what have the results for the patient's been so far? 

Gasbarro: Well, the last one was this past Friday, and I guess the first one would have been, what? Three Fridays ago now. So, about three and a half weeks ago. And, you know, I've seen now the first three patients that we did in their first post op visit. And in the first post op visit, you're really looking at to make sure, neurovascularly, their nerves, their blood vessels, are all working in the arm that you operated on, make sure their wound is healed, and to look at their pain level. So we don't have any outcome data with regard to pain scores, long term, range of motion, long term and other patient reported outcome measures that I keep in my clinic, including some important things for not only range of motion, but also day to day activities. So this is something that is very much new and very much in development and as far as outcomes go, but the science behind the technology we're using, as I mentioned, is FDA approved. It's been around for at least five years now, and it's something that's very safe and it's an adjunct to what I was doing prior with those guides, and it's nice not to have to use the guides on every case now.

News: And could you tell us any more about sort of how you would describe the stage of the development of this? It's been FDA approved and how soon, or what is forecast for making it more widely available?

Gasbarro: The specifics, with the company, I'll leave with them, but it it's a limited market release right now. So there's a group of surgeons that are working on this and putting our heads together to make improvements. Because with anything, things over time need to adapt and improve to make things efficient, and once they're efficient and reproducible amongst this small group of surgeons, it's going to be something that is going to be very, I think, commonplace within the shoulder specialist world, that's doing a lot of shoulder replacement surgeries in the United States. 

So, you know, I think that the technology is there. I think we're working now on, how the holograms interact with us, the instruments we're using, making sure that those are all fine-tuned to make the workflow nice and efficient. And like I said, even with the first set of cases, it only added about 11 minutes to my case, which is significant, because that's important, too for the patient. You don't want the wound open too long. You don't want the anesthesia times to be extended. So, I think that once we do more cases, we'll see what the learning curve is. I think this is all part of figuring out things with this technology. But I really think this is something that surgeons are going to be able to do and in not a lot of time.

News: Another follow up question from Valerie, how long is a typical shoulder surgery?

Gasbarro: There's a lot of variables. If you have a smaller patient, a female patient maybe isn't real muscular. Sometimes these surgeries can be 40, 45 minutes long. If you have a bigger, younger male patient, for instance, and dissections a little longer, sometimes it can take me an hour, hour and 15 minutes. But it's usually not more than that.

News: And for those not familiar with shoulder replacement, how kind of common is that? Are they typically a result of injury? Are they age related? You mentioned things like arthritis, give us all a little bit of understanding of shoulder replacement in general. 

Gasbarro: Well, they're typically performed in older, older patients, and older is, sometimes not based on the number. It's based on the patient's physiology, how their health is. So you can take a really healthy 80-year-old and they could be acting like an unhealthy 50-year-old. So I always look at the physiology of the patient, what their activity level is, what their goals are. And when I indicate patients for an operation, but you know, in general, the two main reasons to do shoulder replacement: one, as I had mentioned, arthritis. So losing the shiny surfaces on the ends of the bone. Bone spurs develop. You lose the joint space. You feel stiffness and pain in the shoulder and sometimes some creaking called crepitus. And the other main reason is, if you lose the rotator cuff, the tendons of the shoulder that are important for the stability of the joint, and you decenter that ball up in the joint, that's another really common reason for shoulder replacement, amongst others. Including proximal humerus fractures, when you break the top of your arm bone. So these are typically for a set of conditions that I commonly see. If you have a high volume shoulder surgeon, they're doing this hundreds of times a year, and then you have a bunch of other doctors doing it at a lower volume and the goal with all these technologies is they're developed is to try to make everybody on the same par, to make sure that at the end of the day, we're all improving the patient's outcome as we do these operations.

News: What do you think more broadly about the use of AI and VR to become enabling technologies like this mixed reality, and what do you think about it being applied to other types of surgery?

Gasbarro: Well, in the shoulder world, we're a little bit behind. So in many other parts of medicine, these technologies have been developed and have been in use, to answer the broad question about AI and MR,I think the first application within the shoulder of AI will be with auto planning. So all this big data that's being created can be brought together in an algorithm that can be at the click of a button, plan your operation for you. So if you again, you take the example of a surgeon who maybe does 10 shoulder replacements a year and is not used to doing the planning, and may have some questions as to where the implant should be and how things should be oriented. If we have an auto planning application, and you group and pool all these prior planned surgeries, and you take a group of experts that do this hundreds of times a year, and that person is able to use that plan, and then they have to go now to the operating room and execute it with this wonderful technology of the goggles that overlays that plan on the surgical field, I think that's the first application of AI, at least in the shoulder world, is leveraging the data that we have and being able to quickly come to solutions virtually preoperatively, and not necessarily, at least right now with execution in the operating room. I don't think AI has a current role in that, but who knows. Let's see where it goes.

News: Another question here from the chat. Are you aware of other systems using this, and how did you learn of it?

Gasbarro: As of right now, this is the only system of, I believe, of mixed reality, that has guidance. So Stryker is the first to the market in this particular, very specific field. I know many other companies have things that are under development, but nothing that is FDA approved and nothing that can be used on a patient in 2024.

News: Okay, any other questions from the media, please do chat them to us. We will have a recording and a transcript created after we're done with the Q and A and those are able to be processed. We'll send them to you. Doctor Gasbarro, is there anything else you'd like to be asked or share about your experience using this or what do you think it can bring to patients with this new technology.

Gasbarro: Well, I'm excited for the next set of cases. I skipped over that last part of that. One question is, when's the next one? Well, we've got some this month. So this is something that on a weekly basis, when I'm in the operating room, moving forward in 2024 we're going to be doing and I think that the results that I've seen with patient specific instrumentation are generally excellent as far as range of motion and pain reduction. And I'm hopeful that this new technology leads to those key things that I was telling you, decreased fabrication time so you don't have to wait for the guide. Improved accuracy in the operating room, and hopefully within those FDA limits that were set, and that's what I've seen. In the first five cases, I've been within two millimeters and two degrees of positioning in all the cases so far. I'm hoping, with this added layer of accuracy, that I continue to see good results with patients having a stable joint that's long lasting, with good range of motion over their head and especially behind their back. And, to make them happy and return to all the things that they love.

News: Okay, thank you very much, Dr Gasbarro for sharing your point of view and insights about this interesting new technology. For anybody in the media, I've chatted the media contact information to Dan Collins at Mercy Medical Center, who can help you with any follow up with Dr. Gasbarro that you'd like to do with that, I'll say thank you to everyone for attending. Thank you, Dr. Gasbarro again for joining us. Namaste, and good luck. 

Gasbarro: Thanks for having me.