How do we make operating theatres safer, and lower risk for patients? What are some minimally invasive alternatives to gastrointestinal and stomach surgery? Curious? Watch now to learn more about the Auckland researchers who are investigating opportunities and possibilities in surgery.
Professor Jennifer Weller is curious, too. She is using 'real life' simulated dummies to improve safety for patients in operating theatres. She is joined by Dr Tim Angeli-Gordon who is curious to learn about less invasive alternatives to surgery. They are working on solving the puzzles associated with the future of surgery.
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Presentation by Dr Jennifer Weller, Head of the Centre for Medical and Health Sciences Education, The University of Auckland and Specialist Anaesthetist at Auckland City Hospital.
“NetworkZ – Better Outcomes in Acute Care”
Thanks for the kind introduction, and welcome everybody this evening.
I am going to talk very briefly about our NetworkZ programme. This is a national program, multidisciplinary in-situ simulation-based team training for surgical and emergency departments.
I would like to acknowledge a large number of collaborators in this work and our funders and also the NetworkZ team and the current NetworkZ team, which are currently delivering the training around New Zealand, and also the network of our NetworkZ instructors, and convenors and participants, and thank them for giving permission to use a lot of these photographs.
This reminds me that I should give a warning that is there are some very explicit photographs of goriness in this presentation, but they all simulated.
So just a very brief history, which began with the pilot project back in 2014, which was partly funded by Health Workforce New Zealand and a project from an AMRF grant. That showed sufficient evidence of some effect and feasibility that we were able to secure ACC funding and that's allowed us to roll this training out across the whole of New Zealand. What we have really established is a network of simulations, simulation, capacity, so ability for teams all around New Zealand to train using this really high fidelity program.
We rolled it out, starting in 2017, and have just completed the roll out last year. We are now moving into a business model run by UniServices, and in parallel there’s been a lot of research along the way.
I just wanted to outline what I am going to talk about and very briefly what NetworkZ is. I wanted to talk about three key patient safety contributions that arise from the program – crisis management, speaking up and latent safety threats – and then touch on some research and evaluation that is wrapping around this program.
The rationale for this sort of training is that adverse events occur in health care and there is not always the optimal outcomes that we would hope for. So adverse events are common, and if you look at the literature in New Zealand about 10% of hospital admissions are associated with some unintended event that caused some degree of patient harm. That is something that happens all around the world, and something that's quite a burden of disease for our communities. In terms of the surgical setting many of the peri-operative events that were adverse were considered to be avoidable, and a lot of those avoidable incidents comes down to teamwork and communication. Just getting the information through to the right people and getting the team organised -so some things that we can actually do something about. In addition to this, it's a lot of the way we design things, the way we set up our environment, there are a lot of hidden threats in those environments that can also lead to patient harm. I'll touch more on that later.
The program of NetworkZ - I’ll try and give you some picture of what it looks like over the next few minutes - but one of the things it does is it engages the entire team. It is actually very rare in healthcare training to get all of the members together. Surgeons train separately to anaesthetists, who train separately to nurses and getting them all in the same room is quite a feat.
We have been able to do that through creating very realistic simulations that everybody can engage in as if they would with their real work. Surgeons are able to operate on the mannequins, anaesthetists are able to anaesthetise them, and nurses are able to work in their own environment to support the surgical operation. This is also national. Because of the funding we receivered we were able to establish this sort of training in every hospital that provides surgical care around New Zealand and that's speaks to equity in that usually those little places don't get to get the big training events that are available for the big hospitals. It's accessible nationwide, and our aim is to build more resilient teams that are more resistant to error. The training is in situ, which means that it actually happens in the workplace, so in an actual operating theatre, in an actual cubical in the emergency department and that, in addition to being very realistic and more likely transfer to practice, it also offers us a chance to stress the system, to stress the environment and uncover those hidden threats to patient safety. It is also a trainer- trainer model. We train a whole lot of instructors and they then go back and deliver the training in their own environment. It is local ownership.
In a NetworkZ course a typical morning would be introductions and familiarisation. We think it is really important that let's get to know each other and get familiar with the environment, so that it's not a big surprise when they go in there. Then there are 2 or 3 simulated clinical scenarios, each lasting about 30 minutes or so, followed by debrief. We really dig into what happened during those simulations to make sense of it. Also, within the training there are communication workshops - looking at how we can improve the way we communicate with each other.
This is a model that we have been using around team work to assist with teamwork training and it seems to have stood the test of time. It is a model that was developed by Eduardo Salas and it's based on observations, empirical evidence of thousands of different teams across a whole lot of different industries. It might also apply to the teams within which you work or move. Think about these components of what an effective team looks like. An effective team has somebody that is in charge - a leader. In an effective team the whole team is able to contribute to the problem solving, the decision making, speaking up with their concerns. It is not just up to one person. The team is able to monitor each other and see where there are areas of high workload and can help each other out. Or you can anticipate what somebody might need and when something changes in the situation they can adapt and rapidly change course. The way they can do this, and the key requirements are, that they've got a shared understanding of what the situation is and what's the plan and what's likely to happen. They all have a shared concept of what they are doing and they must have some pretty good ways of communicating with each other to capture those communication failures, and they also have to have a lot of trust and respect. This comes down to this idea of, if you want to be able to speak up with concerns and share ideas you do have to have a lot of respect, so part of it is about relationship building.
They of course work in an environment, in a culture, and they have their own things they bring to this to the situation that will affect how the team works. Some pictures of simulations. This is a surgical simulation.
You can see how realistic it looks. This is in ED where we are running simulations in ED departments across a lot of the country - at country hospitals and city hospitals. A lot of engagement. This is in the post-operative care unit. You can just see from these pictures how engaged people are with this sort of training. It really is a wonderful way of teaching. People love it and get really into it, so it is very rewarding.
Over the years we have had participation from all hospitals, either in the operating room, PACU or in the ED. We have had over 3,500 people go through our training programs. That is quite a lot of health care workers and a lot of people have been involved in the instructor training. We get very positive reviews. People fill out an evaluation form at the end of every course, and it is always extremely positive. People like this sort of training, despite the effect that it might feel a bit threatening.
I just wanted to show you one or two minutes of a trauma scenario from one of our NetworkZ courses, and this is portrayed by two people that are acting.
This is role playing, and it is a simulation. It is not a real person. This is a simulation of a trauma where a patients come in and they have got a knife in their belly and they've cut something, and things are happening. This is the middle of the operation. The anaesthetist is really worried about the blood pressure, which is really low; the surgeon is trying to find where the bleeding is coming from, and the nurses are trying to deal with all of the equipment. The suction is filling up and they haven’t got enough swabs and things.
You may have noticed that there wasn't a great deal of communication between the teams. The anaesthetist, surgeon and the nurses. It seems like they didn't all have a clear picture of what was what was going on together. That is one of the things that we really draw on in these sort of experiences, to promote that with more of a feeling of it being in a whole team and getting on to the same page.
That us leads me on to one of the things I want to just touch on - how we can improve patient safety through this training around crisis management.
Our courses are training people to respond to particular critical events, for example, to a major haemorrhage, major trauma, or anaphylaxis, so that we do get training on specific events but there's also this more general training for teamwork which can apply, not only to other critical emergencies, but also to routine daily care. Capturing some of the lessons learned from teamwork and communication in this stressful situation and applying them to a routine daily practice.
A little bit about what it is like being in a clinical emergency. It is quite stressful and a lot of the information that you are getting in an emergency is unclear, it's ambiguous and you just don't get the whole story. There is a lot of uncertainty. You might be in a strange environment and the environment may suddenly become very full of stuff and people, and so it can be quite unnerving, stressful and there is also time pressure. You really have to get stuff done. It is amazing how many things you need to get done all at once, and how difficult it sometimes feels to just do them. There is this fear of consequence, a bad outcome for a patient. It really is stressful.
There is a lot of sensory input coming in and you can see that this is not an untypical - sort of messy environment. This is what it looks like in some of our theatres during a high stress event, and there is a lot of input coming in there.
This is a combination of cognitive overload and stress. It really makes it very difficult to think - you get tunnel vision, you miss some really important cues coming in because you just focus in on one thing, so you lose that overview of the situation. It becomes really hard to think and it's just too much for any one person to take in.
If you look at the graph of performance versus stress. This left side of the graph where there's no stress - that's probably not enough, you’re probably basically asleep at that point. Up at the top this is where we want you to be for optimal performance, but if the stress gets too much you descend into this stage of panic, and really, very little gets done at that point. We are trying to modify that stress and that overload, so that it's a manageable situation for people.
We do that in a number of ways, so that it is a way of spreading that cognitive load around the whole team rather than it all being on one person and it can make the whole thing really easy. We start with the planning. If we have got a little bit of time to plan, and we don't always use it in the clinical environment, but we're teaching people to try and get together and do that. Get together with a briefing and plan for what might happen. Think about potential threats. Allocate roles. Consider more resources. In the simulation we are applying that teamwork model that I described before, and people get a chance to apply it.
I love this picture. This chap in ED - that was his stance. He was a stand back leader by not having his hands on anything not engaging in any task he had mental capacity to think. He was there doing the thinking and you can see how much easier that would be to control the situation if you are standing back and thinking. That is one of the things we talk about. Afterwards we get an opportunity to talk about it. It is a very structured debrief. We talk about how people are feeling when they come out of it and we get a description of the scenarios so that everybody has got a clear understanding and an analysis, and then we very much concentrate on what have we learnt that we can take back to practice. That is how I think our teamwork training works to build more resilient teams.
One of the things that has come up in what I have been talking about so far about crisis management training is speaking up. Speaking up is not easy. Thinking of your own situation where you thought, I should have said something then - there must have been lots of instances where you thought that yourself. You think about why you didn't speak up and it's possibly because you thought you might get a hostile response or maybe you thought you weren’t right about what you're thinking, or maybe it wasn't your business even. I guess it's becoming a real thing in health care settings to teach about speaking up now, because we do see it as a real concern, and we think it does need to be everybody's business.
There are a lot of moves around speaking up for patient safety. You will see posters up around hospitals and the interventions team seem typically to be aimed at this little guy. This assertiveness training and it is something like; probe, alert, challenge, emergency. It is escalating the challenge and trying to make it easier for people to challenge somebody that's more senior to them or across a professional group. There is not much evidence that this works. Perhaps it works a bit, but people still don't speak up. We thought the position should be that it shouldn't really require an act of bravery to speak up - it should just be normal.
We flipped it on its head and started thinking about what is it actually like from the perspective of the big guy; the person that you are speaking up to? What does it feel like? How do you normally react? I guess this is a little bit like somebody giving you feedback possibly a spouse or anybody. If somebody raises a concern about something that you have said or done, it’s pretty instinctive often to react defensively. You can probably relate to that, and I think that is a natural reaction.
We wanted to get people to reflect on what it is like to be spoken up to and what sort of things might subsequently unfold after their response. How might it affect patient care? In one of the studies we did, we interviewed a whole lot of senior doctors, senior nurses, anaesthetic technicians, and did an interview analysis using thematic analysis. It came up from what they were telling us, that this model of what it's like being spoken up to, and it does matter what the speakers tone and content is - it can be more or less offensive - but it's filtered through your lens and so it might depend on how you are feeling at the time, whether you’re really stressed, whether you're really trying to concentrate, whether you've had a really bad day or something else is going on in your life which may influence how you interpret that that message.
You might have your own beliefs about personal fallibility, and I think possibly, as we get more experienced, we experience fallibility more often, and realise that it's a really good idea if people speak out with their concerns because it's actually helping us and somebody's got your back so that tends to change with experience.
Obviously, you are less likely to be offended by somebody that you have got a good existing relationship with, which speaks to this idea of building teams and mutual trust and respect, and vice versa. If somebody says something, and you already don't like them, then you’re more likely to respond negatively.
You might have experienced how difficult it is to speak up. So you might have some empathy for the person that is trying to give you this message and be more forgiving of their possibly bluntness. There are also, in our operating theatres, there is a mix of cultures and mix of ethnicities, and there is a lot of different ways of perceiving culture and hierarchy in different cultures and different professions. You might find some more hierarchical structures where you would never dream of challenging somebody more senior than you and you might find that some cultures say things more directly or bluntly.
It also came up that you were more likely to respond positively to somebody who you thought had a lot of medical knowledge or expertise. This was interesting and you can consider it good and bad in that it certainly makes sense, but also it might mean that you just ignore the health care assistant in the corner that says, hey, I'm not sure that this is the right patient and some vital piece of information, because you're not expecting it to come from that quarter. All of these things influence how you respond. It could be very positively; it could be very negatively. A positive response is going to encourage the whole team to keep contributing to the patient decision making but a negative response - everybody’s there and it's not called the theatre for nothing – so you're in a theatre your responses are observed, and everybody says, well, I'm not going to say anything from here on in and people start withdrawing their contributions, and it's less people putting into decisions making, less effective teamwork and patient care is less likely to be optimal.
This sort of work has informed our course. We are using that model to guide reflective exercises, to try and help people to unpack that immediate defensive response and perhaps moderate it, explore the facilitators and barriers to speaking up and aim to create, in your own environment, a space for people where they are more likely to speak up and contribute.
Next is a piece on patient safety I wanted to touch on, and this is the latent safety threats.
Latent safety threats are issues that are waiting to happen but haven't. They haven’t harmed anyone yet but they might. And so they are errors in design, organisation, training, or maintenance, and they may contribute to medical errors and patient harm. In-situ simulation - stresses the system and uncovers latent safety threats, so we don't need to wait for a disaster to happen before we realise that our systems weren’t up to it. We can find that out without having the actual disaster and so resolving these threats can prevent future unintended patient harm.
Our first study a was retrospective audit of the post-course reports that people filled in after each of our courses, and we got reports from 21 hospitals. 77 of these contained reports of latent safety threats across a wide range of things. We thought this was actually quite a lot of things to be identifying in people's departments that were accidents waiting to happen. They occurred across a range of things which fitted in with this classification system.
Some were as simple as just not knowing team members names. If you are trying to ask somebody directly to go and do something, and you don't know their name it a lot harder, and it delays that communication. As an example, there is a massive haemorrhage protocol which helps us to organise how the blood gets to the theatre. The request goes from the patient to the blood bank and then the blood comes, and it comes in a certain order. It is quite a complex system, but there are protocols for it, and testing that system through at simulation identifies often that people don't actually understand the protocol, or it's not been clearly written. Those practice runs help people to sort out those faulty design issues. We often find equipment problems. It is the defibrillator that doesn't actually work or the lack of equipment - something that you should have had available, but you don't. Other work environment things like, if you're interested in ergonomics, just where you put stuff makes a lot of difference to the flow of things whether you can see stuff. People say we shouldn't have that person standing there, we should have them standing here and that helps workflow.
This is just an example. The nurses couldn't find the emergency bell in a theatre when a patient developed severe anaphylaxis and it was because it was hidden. They solve this problem by putting massive red tape right from the floor to the ceiling and so nobody is going to miss that emergency bell anymore.
It is simple things that can make a difference. The current research project is a more prospective look at these post course reports that the course instructors fill in after they've seen stuff in the simulations and talked about it in the debrief.
Getting them to fill post course reports in, following them up in 6 weeks and 3 months and seeing how these latent safety threats are resolved. Also doing staff interviews. We hope to identify at a national level the sort of threats that are hidden in our environments and there are likely to be some very common ones, and also how to get these things fixed. Barriers and ways to facilitate resolving these threats to make our environments safer for patients.
Alongside this, and obviously the funding depended on this, was producing the evidence. So very briefly, we have had a parallel evaluation going right along since we began. Our primary patient outcome measure is trying to look at a holistic measure of outcome for an intervention like this. It is days alive and out of hospital, and it is instinctively true that you're better off the longer you are not in hospital, and whether or not your dead or alive.
It is a holistic measure of goodness and we've luckily got a national minimum data set. That is an administrative data set that that has information on all hospital admissions. We can identify those surgical cases and look for that piece of evidence. We have got about half a million cases to analyse. We are also looking at costs and numbers of ACC claims.
This is the trial design. It starts off on the left-hand side. That is the control - that is before we've done anything. In the middle is the intervention, and then after that is post intervention. We are looking to compare the pre intervention across all of the clusters with the post intervention.
It is the nearest you can get to a randomised, controlled trial in a real-world quality and improvement initiative. There is no way that you can do something like this in a randomised control trial. We are also using process measures looking at observations of teamwork in theatres and also surveys of how people perceive teamwork.
This is some of the concurrent research we have been doing, looking at implementation, looking at how you sustain something like this. We have talked about speaking up, of latent safety threats, doing some work around teamwork and communication and the emotional impact on how this works in the operating theatre, and whether or not some of the strategies in NetworkZ are transferring to practice in fact. Also, looking at Māori perspectives on acute care and lessons potentially for NetworkZ from that work.
In summary, I think NetworkZ has built capacity and capability for really high-quality teamwork training across New Zealand. To think this is actually probably a world first to have a national program like this and I think NetworkZ speaks to multiple components of patient safety and it actually presents both challenges and opportunities for the team training program in the new current healthcare environment.
Thank you for your attention.
Presentation by Dr Tim Angeli-Gordon, PhD, Auckland Bioengineering Institute, The University of Auckland
“Minimally-invasive diagnostics and therapies for GI disorders: from engineering benchtop to clinical bedside”
Thank you. That is a tough act to follow. Thank you, Jennifer. One thing I’ll take away is that stress versus productivity graph. I think I am going to apply that to my own work and try to decrease my stress and become more productive. So, thank you.
Tena koutou, tena koutou, tena tatou katoa Nō Tiamana ōku tupuna, engari, nō Amerika ahau Heoi anō, kei Waitākere ahau e noho ana Ko Aotearoa tōku kāinga ināinei He Pākeha ahau Ko Tim Angeli-Gordon tōku ingoa.
My name is Tim Angeli-Gordon. I am from the United States originally. I have been in Zealand for 13 years now and this is my home. I have got a whanau here. I have got a couple of daughters and a beautiful wife, who unfortunately couldn't join us tonight.
I am very fortunate to get to work with the Auckland Medical Research Foundation and at the Auckland Bioengineering Institute here at the University of Auckland. I went to the University of Michigan in the States.
Today I am going to talk a bit about our research on the gastrointestinal tract and specifically on developing minimally invasive diagnostics and therapies for gastrointestinal disorders with a focus on developing new technology in the engineering lab or on the engineering bench top, and then moving that technology towards the clinic. There is a lot of big words here, and I know Sue had a lot of very technical words in her introduction. Thank you for that Sue, but I will try and break it down as we go, so please bear with me.
I thought I would talk first about my motivation. Why I do what I do and why it is important that we look into this. Gastrointestinal disorders affect about 40% of the world's population. That sounds very high, but that's everything from reflux after a meal, to very, very severe, debilitating complications with the stomach or intestines. I thought rather than talking about all the different disorders and all the different people - I am going to focus on one disorder as the motivation - that's gastroparesis.
Gastroparesis literally translates to stomach paralysis. Gastro meaning stomach and paresis meaning paralysis.
These patients, their stomach doesn't empty normally, and they have very severe nausea, vomiting, abdominal pain, bloating, and when they eat a meal they typically feel full very early but it's pretty much those 5 symptoms that they have an and really most patients with gastrointestinal disorders. I will actually focus on one patient in particular. This is Ruby Hill.
She was quite a high-profile case in New Zealand. She was a real advocate for gastroparesis for a number of years while she was fighting it. There is a whole range of popular press articles. I got these images from a number of different publications, and they say a picture is worth a thousand words. That is Ruby on the left while she was healthy, and that's her in the middle while she was suffering from gastroparesis. The caption says that she is down to 47kgs at that point and this third photo - that's even more striking – when she is down to 22kgs at that point in 2019. Unfortunately, she passed away that year from complications from this disorder. She was 23 years old. Prior to that she was vibrant. I have talked to her family. I have actually been able to do some work with her mother who runs a website and an outreach group, generating awareness and support for gastroparesis.
So it is really striking and so this is why I do what I do. There are many people like Ruby - tens of millions of people who suffer from these sorts of disorders.
The diagnosis is very challenging. In talking with clinicians, they want to provide a diagnosis for people like Ruby, and they feel like they don't have all of the tools that they would like.
It is difficult to even tell these patients a definitive diagnosis of what's wrong with them. And then when we are able to tell a patient that they have gastroparesis or one of the other gastrointestinal disorders there are limited therapies. Some patients respond well to pharmaceuticals, others don't and there aren't a whole lot of options.
Myself and our team, we approached this from a little bit of a different perspective when we looked at the underlying electrical control of the stomach.
What you are going to see here is a view inside of the stomach. It is very similar to your heart where each of your heartbeats, the actual contraction of your heart, is triggered by an electrical wave that causes the muscle to contract.
What we see here is a video from inside the stomach. It is called an endoscopic video and we see these large ring contractions that are moving down the stomach. Each of those contractions is triggered by an electrical wave, and it is those electrical waves that we measure using new techniques to try and develop diagnosis and treatment options.
If there is one thing you take away from my talk tonight, know that the stomach has electrical activity that coordinates the activity. If that is all you take away - I'm happy that's good because most people don't know that. I didn't know when I when I started this journey.
I think it is always interesting to take a look back at history. Here is an image of Professor Walter C. Alvarez.
He is an American based clinician and very prolific academic researcher and he is the person who is credited with discovering the electrical activity of the stomach.
On the right-hand side, we can see an image from one of his very early papers. You can see on the bottom the date is 1922 when this was published and each of those little peaks in that is a deflection of the electrical activity. If you can see in the bottom left of that image there is a little diagram, a hand sketch of a stomach and a couple of lines that denote where the electrons were placed on the stomach. So this is the original discovery of electrical activity of the stomach.
Now, if we fast forward 100 years, which I can do in this presentation, we get to more modern techniques called high resolution electrical mapping.
This is some work that was developed by my research group, others in my research group, and we see on the left-hand side some of our electrode arrays. Each of those gold dots is an electrode. There is 256 of them and they are 4mm apart; so it's a very small patch or a relatively small patch, with many, many hundreds of electrodes which allows us to record this activity in very high detail.
We are able to dictate what direction the activity is moving, how fast it's moving, and many different characteristics about it, that researchers and clinicians weren't able to do with less sophisticated techniques in the past.
A couple of benefits of these specific electrode arrays, are that they are flexible, which means that they can adhere to the curved surfaces of the gut and they are also sterilisable which meant that we are able to translate them into human patients, whereas many of the previous techniques were limited to pre-clinical or animal work. We are actually able to record from human patients, and you can see an image of some of our electrodes inside a patient in surgery at Auckland City Hospital. What that has allowed us to do is create very detailed representations of what the electrical activity on the stomach looks like.
You can see here a model that summarizes these data.
There is a single pacemaker or a single origin where that activity originates. It is midway up the stomach on the right-hand side, called the greater curvature. That activity then propagates down the stomach, or moves down the stomach, and you can see that there is about 3, or even 4 of these electrical waves present at any one time on the stomach. It then terminates at the end of the stomach at what is called the pylorus sphincter, which is the barrier between the stomach and the intestine. So that is what a normal human stomach looks like - a healthy stomach.
If we look in a different view, we can see this is an animation of electrical activity across those 256 electrodes. Again, you can see, it is moving from the top of the stomach to the bottom of the stomach. That is what we see in a healthy case.
On the right is data that we recorded from a diseased case. This is a patient that had gastroparesis like Ruby, who I showed earlier. What we see is that the activation there is actually originating from lower down in the bottom of the stomach, its propagating in all directions, and it's actually propagating up the stomach. So, it is propagating in what we call retrograde - the wrong direction.
We classified a whole range of abnormalities in these diseased patients and it was an important discovery because it linked these measurable electrical deviations with these really complicated challenging disorders. It means that we could potentially use this as a diagnosis - and if we can correct these, we can see if it will actually help as a treatment.
But - the methods that I have described so far are surgically invasive, so we actually have to cut patients open to put these on the stomach, which means that vastly limits their applicability, and we can't go around cutting people open just to see if your electrical rhythms are abnormal. There is no current therapy so if we can find proven abnormalities there is no proven way to actually fix them.
That forms the basis for my work and much of the work of the group. What I will talk a bit more in detail about tonight are three different projects.
The first being to develop minimally invasive electrical mapping techniques. So, rather than having to be surgically invasive, can we develop techniques that are minimally invasive.
The second being, can we develop a way to correct abnormalities when it goes wrong? And we are going to look at a technique called gastric ablation that we have been pioneering in our lab.
Then, lastly, look at some new clinical applications of electrical mapping and whether we can define and give more certainty around diseased patients and what's actually wrong with them.
So I’ll jump straight into the first one of these, which is looking at a new diagnostic tool - endoscopic mapping.
I mentioned earlier in that endoscopic means down the throat. Accessing the stomach down the throat - it is minimally invasive, it is one of the first diagnostic procedures that you get when you have persistent symptoms. The clinician typically wants to go inside your stomach and have a look. Can they see anything that is wrong?
We wanted to know - can we map the electrical activity of the stomach endoscopically using these minimally invasive techniques?
We put our engineer hats on, and we borrowed some equipment and designed some new devices that you can see here.
This is an endoscopic version of an electrical device. If you look in the middle that is the recording end. Each of those silver bands is an electrode. There is 64 of them and they're organised in a sphere. They are linear splines. 8 linear splines with 8 electrodes each. Then we have added a balloon to the middle of that. It is actually a cardiac mapping device, the electrical device, and we've added a balloon and some additional components to make it more specific to our needs in the stomach. The balloon allows it to press those electrodes against the wall of the stomach, which is needed for the recordings, and you can see on the right-hand image from an endoscope of this device placed inside a pig stomach actually in our pre-clinical trials.
Before I get ahead of myself. We first wanted to know - are we able to actually record these electrical data from inside the stomach? We started in our pre-clinical lab, and we surgically placed this new device that we created, and we compared it with our traditional electrode arrays that were placed outside of the stomach. We placed our new device inside, our traditional arrays outside, and we found that the data was very similar.
In the middle we can see the actual electrode traces. Each of those sharp deflections downward is when the actual electrical wave is passing the electrode and then on the righthand side we have got these rainbow looking maps and so you'll see these quite often so I will talk you through this briefly. What this shows is the electrode array, each dot is an electrode and each colour represents the area that that electrical activity has moved per time unit.
On the top one it looks like one second, so each second it moves from the dark red, the next second the light red, the next second the orange. What this shows is the direction of that electrical propagation over the array. What we see here is that we were able to record data from inside the stomach similar to outside the stomach. That gave us confidence that we could move forward with this and we are on to something new and valuable.
One of the challenges was that this new device is very different to our old arrays, which were flat, two-dimensional, evenly spaced electrodes. Our new device is spherical and it is not evenly spaced electrodes - so there’s variable spacing.
What that meant is that our software that we use to analyse the data from our old electrode arrays didn't work for this new device.
That is where Alexander Chan came in, as a PhD student, and he developed custom software that was specifically designed to this new electrode device. I am not going to talk through all of it, because it would be hours of his PhD, which is currently under examination and very close to finishing.
The take home message here is that we are able to design this new software specifically for the device that enabled us to carry on with the work and to actually analyse the data coming off of this device. It allows us to then create maps of activation from this endoscopic device placed inside the stomach.
So here we see activation going from dark red to yellow across 8 seconds. That is showing the electrical propagation of this wave down the stomach.
We thought this was very promising so let us try and put it in actual patients, which I will tell you is very difficult, but we made it.
This is an image of the first ever patient. That's me on the right-hand side and Dr David Rowbotham, who is a Gastroenterologist at Auckland City Hospital on the left hand side and some very talented nurses in the middle and the patient is on the table. You can see our devices being placed on the TV screen. That is an endoscope that's been placed into the stomach.
This was a very exciting day for us and we pushed on with this work and completed a feasibility trial of 13 patients at Auckland City Hospital and this is where another PhD student came on board - Peter Tremain who is here tonight - and he's running this work now in terms of the clinical trials and revisions to the device.
We completed a feasibility trial on 13 patients at Auckland City Hospital along with David Rowbotham. The data was really promising.
Above you can see an example of some of the electrode traces like I showed before. You may be able to notice that those little deflections I pointed out with those red marks aren't quite as clear as some of the other ones.
The data from inside of the stomach endoscopically is not as high amplitude. It's not as strong as data from open surgery but we are able to capture it nonetheless. And the fact that we are able to do it minimally invasively, is incredibly valuable.
We are also able to create these maps of propagation and here we can see that there is actually activity originating from low in the stomach, distal in the stomach, which is abnormal in this case.
This is the first time that we, or anyone in the world, has been able to record in high resolution from many electrodes the spatial propagation from inside the stomach endoscopically or minimally invasively. So we're really excited about it.
And now the question comes, can we correlate this endoscopic data with patient symptoms?
This is where Peter is carrying on with this work and we have expanded to a multi-centre trial. We have now completed 20 out of 20 patients at Auckland City Hospital and 7 out of 20 at Christchurch Hospital, with a secondary gastroenterologist down there, and we are looking forward to trying to correlate abnormal or normal electrical activity with patients who are either sick or healthy.
And so that concludes a new diagnostic tool and a minimally invasive one. But when we are able to diagnose and tell a patient you've got something wrong with your stomach, your electrical activity isn’t working well, what can we do, then?
This is where we are looking at new therapeutic options as well. One of which is called gastric ablation. Ablation is a fancy word for essentially burning the tissue. It is very commonly used in cardiology.
This is a diagram of the heart. A common complication with hearts is that you get abnormal heartbeats which are triggered by regions of the heart activating electrically that aren't supposed to activate. What they do clinically is they feed a catheter up into the heart and they burn those regions of the heart to prevent them from activating electrically. It then restores the normal activation pattern and fixes these patients. It is very commonly used in cardiology and it is a multi-billion dollar industry.
Until we came along no-one had translated it to the stomach. And so we thought - can we use ablation to eliminate this abnormal electrical activity in the stomach?
Another PhD student, Zahra Aghababaie, who has finished her PhD and she stayed on as a Post Doctoral Fellow with us. She is very talented and we're excited to have her.
This time we did it all surgically because it gives us a more careful and managed approach to what we're doing. So we are in open surgery, using these electrode arrays - this is pre-clinical in pigs - put our electrode arrays on, recorded the activity, then identified a pacemaker location which naturally appears in our pre-clinical pig model, so abnormally low on the stomach. It is marked with a star in this diagram. We marked that with a suture so that we could identify exactly where in the stomach that was. We then use an ablation catheter, a common cardiac ablation catheter, that we repurposed for our gastric work. We surrounded this location of abnormality with a box, a series of points made with this ablation, and then we recorded the activity afterwards to determine whether or not we had eliminated it.
Above is a surgical diagram. I show these nice schematics and then this is what it looks like in reality. This is what we are working with.
That is the stomach through an open incision and the ablation catheter is that little blue stick looking thing and those white lines on the stomach are where we have actually performed the ablation.
We are back to these rainbow maps. What we see on the top is that we had activation low on the stomach, where it shouldn't be, and we abladed around that. In the bottom one we could see is that our ablation is that black box and we have restored the normal activation of the stomach. We are back to red at the top, blue at the bottom or, in other words, the electrical activity is coming down the stomach again after we eliminated that abnormal location.
We are really excited about that. We can now eliminate these abnormalities. We have got a new tool to do it.
So the answer to our question – can we use ablation to eliminate abnormal electrical activation in the stomach – YES, we can!