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Top surgeons share insights on future trends in Cardiac and Vascular Surgery and opportunities for Medistim

Capital Markets Day - March 21st, 2023, Oslo Norway
CEO, Kari Krogstad
Medistim – a niche global market leader within ultrasound technology – And a hidden gem with a sparkling future
Prof. John D. Puskas
A heart surgeon’s perspective on the challenges in coronary revascularization – And what is Medistim contributions today and the future 
Prof. Pirkka Vikatmaa
A vascular surgeons perspective on trends in vascular diseases – And and how Medistim contributes to improved quality in surgery and outcomes for the patients
VP R&D Eric Swendsen
VP Innovation Håkon Grøthe 
Innovation at Medistim –  Where voice of customer meets voice of technology
Closing remarks, Kari Krogstad


I want to welcome you all very much this morning to this Capital Markets Day at Medistim. My name is Kari Krogstad, I'm the CEO here. And before actually going into the agenda, I would just like to say thank you to my many colleagues who have helped in preparing for this meeting today. There's always a lot to organize. So thank you very much. Okay. Exciting day ahead. And as normal.

I will start with giving you all an update on the company. I've made, I would say, a bit of a frisky subtitle here talking about the hidden gem with a sparkling future. So, well, that's how I see it. We'll see whether you will agree to that later on. But it's really not me you should come to listen to today, it is our two guests. So we have the big pleasure, I'm very excited, very proud to be able to welcome and introduce professors John Puskas from New York and also Pirkka Vikatmaa from Helsinki. So these are really the experts in the fields of cardiac surgery, vascular surgery, and, you know, all the questions that you may have with regard to what we are doing in this business. Well, maybe they can shed some light on that as well.

We will move on to our presentation from our leaders of R&D and also product innovation. And the day will shed some light about how Medistim is thinking about product development and technology development going forward. And then hopefully there will be both time and some interest from you guys to ask some questions. And hopefully, we have a little bit of a dialog towards the end. So with that, I will get right into giving you the introduction of Medistim. And I know that many of you are acquainted with the company, but not everybody.

We are a global niche market leader within ultrasound technology. And to give you sort of the snapshot of the company today, we are a company medical device. We are developing ultrasound-based technologies. We are concentrating around two modalities of ultrasound. One quantitative method for measuring the amount of blood flowing through a vessel and also high-frequency ultrasound imaging. And the combination of these two. The technologies are used in cardiac, vascular, and transplant surgery to reduce risk and enhance quality. And this is what our surgeons will shed some personal experience and light on. We have been around for almost four decades so far. So we are quite some time still not too many employees, about 130. Our headquarters are here in Oslo. We have a production facility in Horten and we have a large sales organization and we are represented through direct sales forces in the United States, in the UK, Germany, Spain, Denmark, and Norway. And as you might have noticed yesterday we announced that we are from now also going direct in Canada. And this is part of our strategy. I'm very excited about this new addition to our direct sales channel. We already have a strong position in Canada. Just to mention that we have been represented real good distributor of Medtronic for several years and we already are represented in 15 out of 38 cardiac centers in Canada. So it's a good starting point. But we believe that we from now on can actually develop this market further with our own salespeople on the ground.

In addition to this, we have a global distributor network which has been representing Medistim for years, and are present then in all the major markets in the world. There will not be too much clinical information from me. I just want to emphasize that our technology has been extensively well covered and also endorsed by clinical guidelines. There's more than 500 clinical papers out there talking about the use of flow technology and also ultrasound imaging for cardiac and vascular use. So it's a very, very solid foundation and support for the clinical value of using this technology.

I also want to mention that in the early days, Medistim was a distributor of various products in the Norwegian market, and we still have a portfolio of products as part of the company, but it's becoming gradually a smaller part. And based on the last year's numbers, we see that about 15% of our revenues and 9% of the EBIT is coming from this third-party portfolio. But let's go back to our own products and talk about the medical need a little bit background for what we are doing. So we are helping surgeons address issues within cardiovascular disease and we have the experts here which will really give you more details here. But just as a reminder, this is the background for what we are doing and based on information from the World Health Organization, it's still a fact that this is the leading cause of death globally still.

And very often the problem here that we are trying to address is caused by blockages that's preventing blood from reaching out to the vital organs in the body. Disease examples, coronary heart disease, cerebrovascular disease, peripheral arterial disease, and the application areas for Medistim’s technology, coronary bypass surgery, carotid endarterectomy, peripheral bypass surgery. These are some examples of the target applications that we are addressing. And then there is the fact that for the majority of these patients that are in need of any type of revascularization, for the most part, they will receive an endovascular alternative, both for the cardiac surgery and also in the vascular space.

So the big question I guess is that when, for instance, in a coronary bypass surgery, more than 80% of these patients today are getting a stent. Does this mean that we are moving towards 90% or 100%? So is this open surgery going away in the near future? We do not believe it will, but we will learn more from our surgeons to tell us why there will still be a need for these types of surgical procedures for the most diseased patients. And when these patients are going through the more invasive open surgical procedures, of course, it's very, very important that this is worthwhile going through this. And we believe that when the surgeon has done the very, very challenging work of making these grafts it's very important, that they're using objective technology to really measure that. You know, this has been successful, that the grafts are open, well-functioning, they can close the patients and rely on the good result.

So in the middle of this slide, we can see a Medistim probe being connected to a graft. And inside that probe head, there are ultrasound transducers that are submitting ultrasound beams is traveling through the lumen of this artery being reflected. Are we measuring the time it takes for these beams to travel both in the direction of the blood flow and in the opposite direction, and this time difference is then proportional to the amount of blood flowing through. So that's the simple background for the technology. And typically what the surgeons will see when they're looking at the ultrasound device is, well, to the left here we see an open chest and an exposed heart, and we see the Medistim probe being connected to the graft. And if everything is fine, what the surgeon will see on the screen looks something like this graft in the middle, where we see very smooth flow curves we see good flow and indications of low resistance. So to the right on the contrary, we have an example of suboptimal grafts.

We see a more spiky curve, we see less flow, we see more indications of resistance. And then the question is, is it worthwhile to go back and correct this?  

In this case, the surgeon decides to revise the proximal anastomosis, and we can see the results that are appearing. So a much better situation. And clearly, there was a technical error here that was fixable. But sometimes the results are not as clear cut and it's a bit more difficult to know, is it worthwhile to go back and fix this so back in the days Medistim

felt, well, what if we could actually develop an imaging probe that is making excellent pictures in the near field? So take a look inside of these arteries, or anastomosis and take a look inside whether there is a technical issue that can be corrected. That was the idea behind adding high-frequency ultrasound to our device. And the idea was then if the flow measurement data suggest something is not optimal, take a look inside. See whether there is something you can detect a stitch that has been placed wrong, a dissection that has been made or something that you can actually redo with this probe. We are also introducing a new tool and this is providing value all through the operation. So you can start using this for the CABG surgery, start looking at the aorta, making sure there's no soft plaque, no risk of stroke. You can use the probe, the same probe, to check the conduits and also the coronary targets to find exactly where this blockage is located. So all of a sudden we have an expanded value proposition, not only the technology to check whether things are okay, is actually guiding the surgeon during the whole procedure.

I am very pleased to see that this topic of whether to use these types of technologies to elevate the quality of the surgery is still a very current topic and we can see from the very recent years expert consensus statements being published. And I really want to point to this publication from circulation where 19 expert surgeons come together taking a look at all the published literature available out there and coming out with ten consensus statements where the first one is that TTFM should be used on every CABG patient. So this is I think is a great example of a community that is really dedicated to continue to pursue improvement within this space. And this just wonderful to see.

When it comes to the adoption of our technology, it varies widely, but for sure we are moving towards a situation where TTFM has become standard of care, and in particular in Japan today, we would say that more than 90% of these procedures are supported with flow technology and the same almost the same level is true for Central Europe, Germany, Austria, Switzerland, Spain, the Nordic countries is all in the same situation where this is standard of care. We see that other countries are also on the move, pointing to the United States, which has been the number one target market for Medistim for many years already. We are seeing that today more than 30% of these 200,000 procedures are supported with our technology. And this is really proving that adoption is picking up all around the world.

So with the recent establishment in Canada, I've also added that country to this map and we can see that we have more than 30% of the current number of procedures. So, a good start. But interestingly, I'm still talking about coronary bypass surgery. It is a fact that not everybody is using technology, and actually still 55% of the number of procedures performed globally, there is no use of technology, so surgeons are palpating they are feeling for a pulse on these arteries and using that as an indication for a well-functioning graft. So, clearly there is a lot more to be done, a lot of growth opportunities still for the company.

I’ve used CABG surgery now as an example but clearly our technology is also valid for surgical guidance and quality assessment in vascular surgery as well. And it's in particular these indication areas where we are concentrating, peripheral bypass, carotid endarterectomy, and also AV Access and we see already that there is good adoption and a lot of routine use actually on these technologies in certain parts of the world. So in the Nordic countries and Professor Vikatmaa here representing Finland is one of the leading countries with the use of these technologies. So it's going to be exciting to see whether we will be able to really develop these application areas in all the markets as well. Because based on these applications and the size from some of the most key markets, we are adding more than 900,000 additional procedures as targets for the company. And also another 1.5 billion NOKS in annual sales opportunity. So of course, this is a very interesting space for us to go after.

Quick look at the products, just to remind us what we are talking about. This is the Mira™, the latest generation first launched in 2014, takes a little bit of time until you have regulatory approvals in every country. And the most important thing with this generation is probably that it's you can buy it as a flow-only system and then you can upgrade it at the hospital later on to a flow and imaging system. The probes, which are really the sensors, they are sold as consumables, can be reused and sterilized 50 times. There's one family for cardiac use and one family for vascular use. And we also see here the high-frequency ultrasound probe on the picture here. We are trying to offer our technology as flexibly as possible. And you can buy these products either as a capital sales or capital purchase in the US. And also now from this year in the UK, we are offering the technology as a pay-per-procedure model. So out placing the systems and selling smart cards to activate the systems for one operation at a time. Or we are also offering lease models and actually hybrids of these alternatives.

The financial performance, starting by just taking a look at the highlights from 2022. So this was the best year ever for both our revenue and our EBIT, and we're seeing very good growth here. I think the most important thing to notice is the good growth in imaging sales. Of course, we are working hard to convert this flow market to a flow and imaging market. This is growing 44% in 2022. So that's a great sign. At the same time, the flow portfolio is also growing nicely. More than 10%. And then vascular is also really taking off with sales growth of 27%. But the cardiac is also keeping up very nicely at 18.8%. And we can see that all the geographical regions are contributing, but the US is really leading the way here. It's the best EBIT result we have achieved and the best margin as well. And it's the way we like to see it.

Mentioning US and this is just to show how the number of procedures has been growing per year, about 12% since 2013 per year. So really showing that it's a great adoption of this technology going on in the U.S. at the moment and has been so for some years already. So this means that we are actually adding another strong year to our history. We can see here the ten years CAGR for sales is at 10.4% and ten years CAGR for profit is 13.1%. So consistent and very nice results. We are also showing strong cash flow, high equity ratio, no long-term liabilities, and return on invested capital of 49.5% last year and the positive trend curve there as well. And the last we have had our policy to pay off dividends since the IPO in 2004. And there is a proposal now for the General Assembly of paying out 4.50 NOK per share for 2023.

Looking at the future and how are we going to continue this growth story here on this slide. I’m trying to depict, if you’re looking at the various segments for growth, we can see that CABG surgery represents a 2 billion NOK annual sales opportunity for us. About half comes from the flow technology and half comes from imaging. Vascular surgery, adding 1.5 billion additional, about the same in flow and in imaging. And there's also something here called other open heart surgery, which is the use of our probes or imaging probe for other applications. Not something that we are really strategically driving, but it's an opportunity as well. And this is just indicating the current sales and showing there's a lot of open opportunity here.

So how are we going to capture this 4.5 billion NOK of opportunity? And this is the current sales or 2022 sales of our own products. Of course, we want to continue to grow in CABG, win new hospitals, win new users the same in vascular, grow with the flow its large markets remaining both for CABG and vascular, high-frequency ultrasound imaging relevant for both CABG and vascular, and grow the use of the imaging probe in other open heart surgery. Last but not least, go direct in more countries. As I mentioned, Canada as of yesterday, We can see that the trends are positive.

We see a tendency to accelerate the growth for the totality of our own products, but certainly so for the imaging portfolio and also for the vascular products. And how we are going to achieve this is by addressing the flow market and working to convert that installed base to a flow and imaging technology. Work on the markets. We are we have not achieved complete routine use yet, but are working hard every day to achieve that. And also looking at emerging market which have more hypersensitivity and going out there with some adapted versions of the technology to really fit with that expectation.

Working of course, to develop this vascular space. I mean, we have excellent track record and experience from doing this from the cardiac side and we feel that we are developing the vascular now very, very nicely as well. Direct market coverage again. So that's the strategy. And finally, just taking a look at the profitability and whether this should be possible to continue to improve margins here. So we see that we have had a continuous improvement in EBIT margin for the company in gray here in the total margin.

And then we see that for our own product, which is the highest, obviously a 30.9% in 2022. And by seeing that the growth of our own product is higher than the third party products, this will continue to drive margin improvements. Also, the fact that sales of MiraQ with the ultrasound provides a higher margin. Sales through our direct sales channels. Now USA, Canada, more countries will come. And also longer term, I would say we are working on production process improvements where we will see efficiency gains and improvements in the gross margin as well. So there are reasons to believe that we should be able to continue this good development. That was actually my introduction.

The next very important and interesting part of this meeting today is then to introduce our first speaker, and that is Professor John Puskas from New York, from Mount Sinai Health System. And we have had the pleasure of working with John and his colleagues for actually a number of years already. And he is really one of the thought leaders within this space. He's speaking at all the major conferences every year and has also established a new conference for coronary surgery, which is pretty amazing.

He is in the forefront of developing and testing out new technologies and techniques within the cardiac bypass space. He was also a lead investigator on the REQUEST trial, which I hope most of you are familiar with, which was a very, very important trial, which was really demonstrating the clinical value for combining flow measurements and high-frequency ultrasound in CABG surgery.

Thank you, Kari. Appreciate it very much. It's a delight to be here. My second trip to Oslo and I'm sad it's going to be a brief one this time. So I'm going to address the issue of the role that Medistim plays in coronary bypass surgery present and I would argue also into the future. These are my disclosures, perhaps the most important of which is that I serve as a consultant to Medistim, having signed on very recently. And the reason I agreed to serve as a consultant to Medistim was because the corporate mission of Medistim is directly aligned with my own professional and academic mission, which is to improve the quality of care of coronary bypass patients globally.

What is coronary bypass surgery? Well, it's frankly the only surgical therapy for the number one killer of human beings. Let's just pause for a minute and absorb that concept. This is the only surgical procedure devoted to combating the disease that kills most of us. It's not going away. Blood vessels from elsewhere in the patient's body are harvested and redeployed to the heart, becoming conduits to deliver blood supply to the working muscle of the heart beyond a blockage in one of the native coronary arteries. So what future will coronary surgery have?

Well, of course, we will have to invent the future, and that future will demand that we innovate and collaborate to create new technologies and techniques and to train young surgeons to perform these procedures. It will require collaboration between industry and academic and professional leadership in order to improve the procedure. And as Abraham Lincoln is quoted as saying, the best way to predict the future is to create it ourselves. Medistim will play an increasing role in assessing or addressing the value imperative. We are pushed continuously to provide better value to our healthcare systems, to the insurers, to the federal government. And of course, value equals quality, divided by cost.

What Medistim does is improve quality. You saw this slide earlier from Kari. Coronary bypass surgery is expanding globally, and the adoption of TTFM technology is also expanding. But more remains to be done. I'm going to predict that the future of coronary surgery will include many more cases, not fewer. And I'll show you why. The population is aging. We, as a global species, are undergoing an epidemic of diabetes, what we call cardio metabolic syndrome, obesity. And there's a global expansion of coronary bypass surgery into markets and countries that never performed it before. In fact, coronary disease is occurring in younger and younger patients in the developed world as well, and they are referred specifically for multiple and all artery bypasses, which is what I specialize in. I'm busier than I can possibly keep up with in New York City because of obese, diabetic young people. I now operate, most of my patients are younger than I am, and I'm not that old, and they're diabetic and obese and they have multiple blockages. And because they have multiple blockages in multiple vessels and they're diabetic, they're much more suited to be cared for with coronary surgery than with multiple stents. But this does require a more complex operation. And in some cases, we're dealing with patients who've had multiple previous stents. And that raises the bar in terms of complexity of the surgery.

There's an increasing demand for less invasive operations, even as the procedure itself becomes more complex. And I'm going to show you some data at the end of this talk to support the statement that I believe the gatekeeper role of the interventional cardiologist will transition away. Presently when a patient receives a diagnosis of coronary artery disease, we delineate the blockages in the arteries by performing a coronary angiogram. A catheter is inserted either through the femoral artery or typically the right radial artery and dye is injected into the coronary arteries. And an sinave x-ray is taken, a sinave fluoroscopy is taken. And that makes images directly of the coronary arteries a rather invasive way of documenting or diagnosing the exact location and number of the blockages. That also means that the person is doing that procedure is the first one to talk to the patient about what should be done about those blockages. And that person is an interventional cardiologist who does not just perform diagnostic angiogram, but also performs stenting procedures. So this is what we call a gatekeeper role. For a patient to be referred for surgery, the individual who made the diagnosis and who also makes a living putting in stents, must say no stents, you should have an operation. And while many practitioners will do that appropriately, some will not. And so you see wide variations in different cities, different practices, different hospitals in different countries, in the ratio between stenting, what we call PCI percutaneous coronary intervention and coronary bypass surgery, the surgical treatment, the ratios vary by a factor of ten across the globe. Obviously, humans don't vary in their biology by a factor of ten across the globe. This is human behavior at work, and a big part of that is that the patient first hears about the diagnosis from a physician who makes a living doing stents. This is the gatekeeper role and it's going to disappear.

Not only is that role going to disappear, but the onslaught of diabetes is a global problem. Diabetes and what we call the cardio metabolic syndrome is indeed a global epidemic. And interestingly, at the epicenter of that epidemic is the world's most populous country or most populous democracy, India, where we now have almost 60 million diabetic patients. How many times that's something like what, ten times the population of Norway? And the burden of cardiovascular disease continues to rise. India, China, markets that are we haven't even begun to scratch the surface. And this is these are slides provided to me by Dr. Om P. Yadava the president of the Indian Association for Cardiothoracic Surgery, and a good friend. I asked him what's going on in India with coronary bypass. And he put together these slides and emailed them to me just two days ago, estimating that in 2022, India performed about 160,000 coronary bypass operations. In 2023, it will pass the United States as the country performing the largest number of coronary surgeries on Earth. And that will continue.

So why does diabetes drive coronary bypass surgery? Well, this is the Freedom Trial. The take-home slide from the Freedom Trial, published in the New England Journal about a decade ago. And these patients were all diabetic. They were randomized to have either multiple stents or coronary bypass surgery in a random allocation. And after two years of follow-up, you can see that the death, the rate of death, stroke or myocardial infarction, heart attack began to increase the PCI group and was not increasing as much in the coronary bypass group so that the curves diverge over time. By five years, there was a dramatic benefit for coronary bypass surgery compared to stenting for diabetic patients. And this is still the primary driver of coronary surgery. At seven years mortality alone, not just the combination of mortality, myocardial infarction and stroke, was in favor of CABG by an accelerating margin over time. Why does that happen? Thorsten Dunst from Germany published this just a couple of years ago in the Journal of the American College of Cardiology, describing the benefit of coronary bypass surgery compared to the benefit of stenting. When we put in a stent, the point, do we have a pointer? There it is. Got it. Okay. When we put a stent in a coronary artery that has a blockage, we open up a flow-limiting lesion, but adjacent lesions that are not flow limiting are not stented and they remain. And they are also typically more numerous than the flow-limiting lesion. So in the future, rupture of plaques and thrombosis that can occur in these non-flow limiting lesions drives myocardial infarction rates in the patients who have had previous stents. And in fact, stenting does not prolong life. It relieves symptoms, but it doesn't extend life. There has never been a trial demonstrating that stents prolong life in patients with stable multivessel coronary artery disease only in the setting of acute heart attack do stents prolong life. But coronary bypass grafts function very differently. The coronary bypass graft delivers an alternate source of blood to the coronary artery beyond the proximal flow, limiting lesion and adjacent non-flow limiting lesions. So that if in the future these lesions close, the patient doesn't even notice. There's no heart attack. The patient goes on with their day and doesn't notice because these bypass grafts are providing alternate sources of blood supply. They, in effect, prevent future myocardial infarction and protect the patient against events in the future. And that is fundamentally why coronary bypass surgery will never go away. Certainly, stents will never eliminate coronary bypass. And I would argue that we have passed the peak. You've talked about peak oil. I'm talking about peak stenting. I think we just passed it because of diabetes as an epidemic on our planet And because of the last set of images, I'm going to show you that the gatekeeper role for PCI operators is about to end. Nonetheless, coronary bypass has some problems.

One of them is that we cause strokes in about 2% of our patients and it's a big problem. This is the same trial, the Freedom Trial, that showed that after five years, the rate of stroke in CABG patients was about twice what it was in stent patients and most of that occurred at the time of surgery. So we need to reduce the rate of stroke. And that's where that's one of the primary benefits of Medistim technology is to interrogate the aorta in the operating room and guide the manipulation of the aorta so that the surgeon can customize the procedure for that particular patient to minimize the risk of stroke. Because I consider this the Achilles heel of coronary surgery. There's almost nothing more disheartening to the surgeon than to fix a patient's heart and damage their brain. They don't think that's a good trade for the most part, and they're right.

Now the use of the epicardiac ultrasound, I call it ECUS, epicardiac ultrasound or high-frequency ultrasound, the same thing. These are the imaging probes that Medistim sells, they’re endorsed in the guidelines from numerous cardiologic and cardiac surgical societies around the world. But interestingly, not routinely performed. It's like the Pirates of the Caribbean phrase. You know, the code is really not a set of rules. It's a set of guidelines. Right? You don't have to necessarily follow them. And in fact, practitioners often don't. Laypeople may wonder, how can that possibly be? Well, it is, but this represents opportunity both for improving outcomes for CABG patients and frankly, for Medistim because it's from improving outcomes that Medistim will demonstrate value.

So here's some of the images that we can get from the Medistim device. And you can see this aorta is thickened, it's irregular. This is shaggy calcified cholesterol and atherosclerosis. If we apply a clamp to that aorta, we are likely to embolize debris. And feeling the aorta doesn't replace an echo image. This is an aorta here. That circle is the aorta. This thing here looks like a stalagtite from one of the caves in Norway, but in fact, it's just exuberant atherosclerosis in the aorta. And if you put a clamp across that, it will dislodge, embolize and cause some devastating problem. But it's not just those dramatic ones, much less dramatic disease within the aorta can also embolize.

My new friend and colleague from Helsinki, a vascular surgeon, will know that this medial thickening can sometimes be like toothpaste. It's and if you apply a clamp to that and fracture the intima, this toothpaste can embolize and cause significant downstream problems. And this is often not palpable. So I commonly avoid aortic manipulation entirely by using what we call a no aortic touch coronary bypass using bilateral internal thoracic arteries. The left and the right and a radial artery used to extend those to provide multiple outflows to the three different arterial territories of the heart, avoiding manipulation of the ascending aorta that may contain calcium and cholesterol.

And in fact, the European guidelines suggest or recommend by a Class I recommendation, the highest level of recommendation that we should minimize aortic manipulation and that we should perform epi-aortic ultrasound. So this is the Medistim device we're talking about with a class IIa recommendation. So, you know, it's interesting, I'm sure for a layperson to see these are Class I and Class IIa recommendations in the European Guidelines, and yet not all of Europe is doing it. In other parts of the world are worse, not better.

The other device that Medistim sells and which I use every day is this transit time flow meter technology. The so-called flow probes also endorsed by guidelines, but not routinely performed. And that represents opportunity for improving outcomes for coronary bypass patients by ensuring that every bypass graft is patent and in other words, open at the conclusion of every coronary bypass operation. What does that do? It prevents early post-operative micro infarction, which is commonly a fatal event and therefore saves lives.

So I'm going to show you some of just a very few slides from the REQUEST registry Kari mentioned this study which Medistim funded. I had the privilege of participating in it with other leading surgeons from around the world. Actually, we enrolled 1000 patients at seven sites in Europe and North America. All of these patients were having coronary bypass surgery, and this was a nonrandomized observational study. We performed our regular coronary bypass operations and used routinely TTFM and HIFU or ECUS during the coronary bypass operation. And the purpose of this was to try to figure out whether these technologies, the flow probe or the imaging probe would change what we do in the operating room. And of course it's shown on this MiraQ device. Interestingly, about one quarter of patients had some adjustment in the surgical strategy directed by information provided to the surgeon from the use of these devices. That's a big number, especially when you consider that worldwide there's almost a million coronary bypass operations performed annually. This means a quarter of a million patients would have some alteration or refinement of surgical strategy. If every surgeon used the Medistim tools. About 10% of those were in changes in how we would otherwise manipulate the aorta, and that's to try to reduce the risk of stroke. About 20% were identifying the best spot on the coronary artery to do the anastomosis because you can't see through the wall of the vessel with your eye. You can't see this thing on the back wall of that vessel. But if you plug your bypass graft in here instead of here, if it's above instead of below the obstruction, you've got a problem or the patient has a problem. And about 3%, and this is a big number to surgeons like, whoa, 3%, really, that 3% of the anastomoses, the thing we surgeons pride ourselves in being able to do connect one artery to another 3% were revised, in other words, redone in the operating room based on low flow or high pulsatility index, And after revision, better outcomes. And you saw, Kari showed a case of a similar sort of identification of a problem based on low flow and revision of the graft with improvement of flow.

So I'm going to show you some cases from my own operating room. I work at the Mount Sinai Health Care System. I lead the Department of Cardiovascular Surgery at Morningside Hospital in New York. I teach residents and fellows coronary surgery. I try to do it in such a way that they learn and the patients don't suffer. Sometimes I fail.

Here is a resident learning to harvest what we call a skeletonized internal thoracic artery or internal mammary artery. But even before we use that artery, we notice it does pretty meager flow. And there's a localized purple region in its midsection. When we look at this with the ultrasound, we can see a flap in the artery and there's a local dissection. What is a dissection? The layers of arteries, the walls of arteries have layers, typically three layers. And those layers are like plywood.

One quarter inch plywood is hard to break over your knee. In fact, you can't break a quarter inch plywood over your knee. But if you soak that plywood in a puddle for two weeks and then come back and the layers of the plywood are laminated, you can break individual layers with your fingers and you can certainly break them over your knee. You can break a simple piece of pine one quarter inch over your knee. But if the layers of the plywood are together, you can't break it over your knee. It's strong because of the layers. If you break the layers apart, it becomes weak.

A dissection is when the layers of the wall of the artery are split by a crack in the inner layer and blood traveling between the layers and that limits flow and ultimately closes the vessel. So we call this a dissection. The layers of the wall have split apart, and that is a really bad thing. We can't have that. So what we did was we identified the local dissection, we cut the vessel in half, we removed the part that was damaged. We put it back together end to end and then used it for bypass grafting. The ECUS or HIFU told us where to go, where to cut.

So now this is the second case. If we put the internal mammary graft to the anterior wall of the heart, the LAD, the most important artery in the heart, and the flow is mediocre, what do we do?

I had helped my senior resident perform a four-vessel bypass, and this was the flow to the LAD. Just five cc's per minute with a pulsatility index that’s higher than five. And a very spiky pattern here. Not what we want to see. And we were guided by the Medistim to redo that graft even though the patient was stable. This is an off-pump bypass. The heart is continuing to beat throughout the case. And in fact, it was not apparent clinically that there was a problem with that graft. But with the TTFM, we saw that there was. And when I redid the graft, we had a flow of 23 pulsatility index, less than three, a good diastolic fraction, and a good graft. So this patient left the operating room with the most important graft working very well because we used TTFM and had we not used TTFM, we would have left the operating room with a defective graft.

I had seen or thought I'd seen every stitch placed by my junior during the anastomosis, but the end result was not acceptable. We redid it looking at the vessel anastomosis and as we took it down and redid it maybe there was a little asymmetry at the toe, perhaps one of the stitches near the toe of the anastomosis had not been perfect. I extended the anastomosis, redid it myself, and we had a much improved outcome. But the take-home message to me was that the problem with this very important graft was not evident by other metrics in the operating room. We would not have known without the TTFM. We would have missed that. This is quality trying to get from a 98% perfect result to a 100% perfect result, you have to be looking with technology that exceeds your eyes and your hands.

Another use for the HIFU or ECUS is to find coronary arteries. Most of the time we humans have coronary arteries on the outside surface of the heart, just like the veins on the back of your hand are visible. But about 2% of us will have those arteries buried in the muscle, invisible on the outside of the heart. And that's a problem for the surgeon to try to find those vessels, especially in a beating heart. So here was a middle-aged gentleman younger than I having a coronary bypass. We open the pericardium, the sack that holds the heart, and we cannot find this most important artery. The left anterior descending artery. We used the ECUS device, and it allows us to find the ideal site to cut down through the muscle, to find the LAD and graft it. And we did this without a problem and the patient did well. These are the images that we had. Here's the Epicardial surface. There is muscle. This is the left anterior descending artery. You can see a little hump in it. That became our target. This is more muscle between the artery. And this in here is the cavity of the pumping chamber of the heart, the ventricle. Obviously, we don't want to cut into that. That's a cardiac perforation and that's a bad problem. Difficult to fix. We want to find this spot without finding that spot. And we're able to do that.

Another case of an intramyocardial LAD using the ECUS. And this is again, why the imaging is becoming almost equal in value to the flow for Medistim and for us surgeons, a great example, we had very recently an older gentleman from England on a cruise ship arrives in New York. He's with his girlfriend. Interesting. And he has a heart attack before they get to New York. Life is good and he gets to New York. He's brought in an ambulance to my hospital and she goes back on the plane to London. And he has a weak heart, the ejection fraction is low. He suffered a significant marker infarction. We recover him medically and then bring him to the operating room for an off-pump bypass, he needs a double bypass and we're going to use bilateral internal thoracic arteries. But when we open the pericardium, we can only see the left anterior descending at the tip of the heart, the distal end, where it's pretty small and the internal mammary arteries or internal thoracic arteries will not reach all the way out there and we can't find the LAD more proximally. So what do we do? We're going to use this technology. These are the images from his heart. Here's the surface of the heart way down here is the left anterior descending artery. And right there is the chamber of the heart. So in this gentleman, his LAD was so deep in the muscle that it was intimate with that, with the inside of the pumping chamber, of the heart, the ventricle. So that is truly no man's land. We can't go there. But as we go towards the tip of the heart, we find that the LAD is rising up in the muscle, and we can then find a spot where we can reach through a thinner area of muscle with some safety beneath us to bypass that LAD. So that's what we did. We did a little fancy work with the two mammary arteries, cutting one off and sewing it to the other in order to reach to the apex. And we ended up with this result. There's the left mammary artery coming to the lateral wall of the heart and the right mammary artery attached to it coming down to the anterior descending coronary artery.

And here is the flow in both of those. The right mammary to the LAD with great flow and the left mammary to the circumflex with great flow. So routine flow assessment should be considered. It’s a IIa recommendation in the European guidelines from the European Society of Cardiology and the European Association of Cardiothoracic Surgery. I think it's actually bizarre that coronary bypass is the only major vascular procedure that does not require routine confirmation of graft patency at the end of the case.

Now I’m going to show you a couple of slides about a complex operation that also requires a flow meter. This is what we call hybrid revascularization. It's the planned combination of surgery and stenting in the same patient, typically for two different territories, we're going to combine a robotic bypass with a stent in a coronary artery. I'm going to show you this one case, two vessel, coronary artery disease in a Jehovah's Witness. This is a religious group mostly in America, and they refuse blood transfusion. They would rather die than have a blood transfusion.

He had other medical problems as well, an unstable angina. This is his coronary angiogram. I mentioned that gatekeeper role. This is a traditional coronary bypass, coronary angiogram. And you can see a blockage right there. And here also a narrowed segment of the right coronary artery. And so this is the operating room setup. We have standard monitoring. This is of the robot and the patient is actually on the table here. And the console where we're going to work is in the corner of the room. We connect the robot to the trocars, which are inserted in the left chest.

And then I sit down at this machine and I put my head in this machine and I have binocular 3D vision inside the chest. And that's a trocar in the chest. Through that trocar, we insert these instruments, and then those instruments are used to harvest the internal mammary artery that's hidden behind the glistening layer inside the chest. And here we are using cautery to harvest that we're going to make tracks and harvest that artery. Then we connect that internal mammary to the LAD through a little incision. You can see us using the camera to identify the right spot for that incision. The incisions just about that long is about three and a half, four centimeters. And there's my fingertips. Give you some perspective to the size. That's the heart down there. And we're going to sew that internal mammary to the LAD. But when you're doing an operation through limited access, you especially want to know that the flow is good. So we always use the transit time flow meter in that setting. And in this particular patient, we had a lovely flow and a low pulsatility index. And then after that, the patient has, the next day the patient has an angiogram and they stent the right coronary artery and the patient can go home the following day. And here he is four weeks later with very minimal incisions and no incision in the center of the chest. So this is a popular thing for patients. Only a small fraction of patients actually have the right kind of blockages for this procedure. But when we can do it, we always use the transit time flow meter. And it's a popular thing for patients.

Now, this is my last little set of slides. This is about the gatekeeper role, and this is a trial that's ongoing, the so-called FASTTRACK trial. Some of you may know the name Patrick Serruys. He's probably the most famous living cardiologist in Europe. Very controversial gentleman. He's almost 80 years old now, and he's reinvented himself, doing a very controversial clinical trial called the FASTTRACK Trial. Previously, he created the scoring system that's called the syntax score to quantitate how complex and extensive are the blockages in a patient's heart and using that score to allocate the patient to have either medications, stents, plus medicines or surgery plus medicines. And now he's gone a step farther and testing to see whether CTA, CAT scan angiography, noninvasive coronary angiography combined with what's called fractional flow reserve by CAT scan. These are digital assessments of the coronary arteries without catheterization. It's a four-minute scan with a simple IV in your hand, no catheterization of the arteries, zero risk, zero discomfort. It is the future. And I had a glimpse of the future because I volunteered to be the only surgeon in America, North America, enrolling patients in this trial. In this trial, patients are referred for coronary bypass on the basis of an angiogram they've already had. Then a non-operating surgical team mate of mine says, yes, that patient should have a coronary bypass surgery. Then the patient agrees to be in the trial, agrees to have this CAT scan, angiogram and CAT scan, fractional flow reserve. The software is provided by a company called Heartflow in California, and I, the operating surgeon, see only the noninvasive images and plan and conduct the operation based solely on that without seeing the coronary angiogram.

So I've done maybe 8000 heart operations in my career, at least five and a half thousand coronary bypasses. This is the first time I've ever operated on a patient based solely on a CTA. At 30 days, the patient gets another CTA/CTFFR, and what that does is it tells us what bypass grafts the surgeon actually did, whether they are open and what is the residual burden of coronary artery disease in that patient, the so-called residual syntax score.

So here's my first patient from the end of November. So this is quite recently I've enrolled ten patients in this trial. The trial will have 114. It'll finish very soon. In the next month or so we’ll complete enrollment. But this is the very first one and the very first CTA I'd ever worked with. These are the images we get. You saw the images earlier of the coronary angiogram. This is what we get with a CAT scan, 3D reconstructions of the heart actually showing us digital images of the arteries. These numbers actually indicate the surgeons use words.

Cardiologists use numbers to identify the specific branches of the specific arteries on the heart. It's like dentists describing teeth with a number. It's like their own code. This is the cardiologist code. So I learned to speak their language in numbers. But also the machine will create these images too, which show the calcium in the blockages in the arteries of the heart. Then it breaks down to right coronary artery. And these all the images of the right coronary artery with careful identification of the blocked areas, then the machine digitally linearizes this vessel and tells us the distance between the blockages.

So I can plan my bypasses with specific digital information. And it does that for each of the arteries. Now we're at the LAD and we see all the blockages in that vessel. We identify each one of them. We can see them up close, we can linearize the vessel, measure the distance between the blockages to help me plan my bypass operation. So the same with the left circumflex artery, all the blockages and the linearized vessel. Then it produces this thing called the syntax score. I mentioned that earlier, Dr. Serruys created this and it's very important because if your syntax score is less than 22, you should either have medicines or a stent, but not surgery.

If your score is between 22 and 32. Stenting and coronary bypass are both alternatives, depending on the feasibility and geometry of the blockages. Above 32, all those patients should have coronary bypass surgery because stents are actually dangerous for the patient. Just too much metal, too many stents. 66 is kind of off the charts. That's a really sick patient. They should clearly have bypass surgery and that's a lot of blockage. Here's the real reason that the gatekeeper role is going to disappear because there's an AI algorithm, the syntax score II, that Dr. Serruys has created, which will tell us the ten year mortality with PCI versus the ten year mortality with CABG or the five year event rate for major adverse cardiac events, death stroke, MI for PCI or CABG. And you can see that there's about a 20% difference in survival over ten years for this patient with such extensive disease in favor of CABG over PCI.

If this information were presented to the patient by a non-biased clinician, decision making would be different and allocation of patients to different therapies would comply to the guidelines more and I would venture to guess that the ratio between PCI and CABG would become much more uniform across the globe. The machine goes on now. Now this is AI, it creates this. What do you want to call this? A cartoon of the coronary arteries of this particular patient with each of the branches and their color coded to indicate the restriction of blood flow. And they are numerically labeled to tell us the actual physics of the fractional flow reserve at that point on that artery. And that guides my coronary bypass operation. And you get a functional syntax score. This is what we planned to do. I planned to use the right mammary and the left mammary. The right mammary with a piece of radial is going to go to the posterior descending artery, that's number four and then around the back of the heart to the left posterior descending, which is 14 B the left mammary is going to go to the diagonal number nine and to the end of the LAD number eight and a piece of radial off the side of that over to the first obtuse marginal vessel, which is 12 a. That was what I planned to do and indeed that's what we did. So we did what we would say we would do. So how did that work out? Here are the studies. The same patient repeated study at 30 days after surgery, and we can see that all the bypasses are what we said they were going to be and they're all open. So here's the right mammary with a piece of radial going to the posterior descending and around the back of the heart to the last branch of the circumflex system. Here we can see it here to 4 and 14b. Here's the left mammary touching down on the diagonal here and on the LAD here and a piece of radial coming off it, going over to the radial off the LIMA coming over to the obtuse marginal. So now the residual syntax score, which was initially 66, is now two.

So this patient no longer has significant coronary disease at all after five arterial bypass grafts. That's without having a diagnostic coronary angiogram involved in their care. So if we can take a patient with this number and make it this number, then the gatekeeper role of the interventional cardiologist, the days for that are numbered. It's not going to go on forever. And as a result, more patients will be referred for appropriate coronary bypass. I think you'll see that AI will drive this and insurers and federal payers will say we're not paying for six or eight or ten stents at intervals every six months for the next five years. If the AI algorithm says a patient should have coronary bypass, that's what they are going to be presented with as an option. And so I think you're going to see a significant uptick in coronary bypass based on this technology, this is a visual I'm showing you one patient, my first patient has now gone through the 30-day follow-up of a trial that hasn't been completed and has not been published. So I don't know what the trial's going to show. I can tell you what it's showing in my patients is that we don't need a diagnostic coronary angiogram, and that means a gatekeeper role for the interventional cardiologist is doomed. And that will mean more CABGs.

I've been thankful to Kari and to Medistim because they've been very helpful in promoting the field of coronary surgery. We dedicated a chapter in our, David Taggart from Oxford, and I published this recently with the Oxford University Press. It's the only big textbook devoted solely to coronary bypass surgery. And there's a whole chapter on using TTFM as a quality assessment tool in coronary surgery. Medistim has also been actively involved in supporting the International Coronary Congress, which is the only annual meeting that is devoted solely to coronary bypass surgery. We have it every other year in New York It was New York in its inaugural year, then in New Delhi, New York, Beijing, New York, COVID, COVID and we were in Tokyo just a few months ago. We will be back in New York in December of this year and in London in December of ’24, rather. Among the many topics that we discuss are intraoperative graft assessment and quality control, because this in the end is what we do. We have to demonstrate that before we close the patient, the bypass grafts are working and we have to do the surgery in a way that minimizes the risk of stroke. And so now I get back to my first comment. The reason I agreed to be a consultant to Medistim is that they only sell two things, And those two things are devoted to reducing the risk of stroke in coronary surgery and ensuring that bypass grafts are patent in coronary surgery that promotes quality in the only surgical procedure that is dedicated to fighting the number one killer of all of us. Thank you.

I’d like to introduce our second speaker,and that is Professor Vikatmaa from Helsinki.And Professor Vikatmaa has also been working with our technology for a long time,really extensive experience from the whole field of vascular surgery,both endovascular procedures and open surgical procedures,many, many procedures with our equipment under his belt. He was former board member on the European Society of Vascular Surgery, currently the leader of the Finnish Society of Vascular Surgery.  So also a thought leader within his space.

Good to be here. And I could not agree more with John on many of the of the things I am talking about peripheral vascular surgery and what is peripheral.

Good to be here.

And I could not agree more with John on many of the things. I am talking about peripheral vascular surgery and what is peripheral. Why did I become a peripheral vascular surgeon? It was because it's more agile. Agility is modern wording in business as well.

And we haven't done diagnostic angiographies for 20 years or so. So now we do MRA, we do CAT scans, we do ultrasound, and we base all our operations on noninvasives. And I would agree with that in carotid surgery; it took like one or two years before everybody abandoned the catheterizations.

20 years ago, I had to choose between cardiac and peripheral vascular surgery, and cardiac was a very established thing, whereas peripheral vascular surgery was growing very fast. There was new innovation, and it was, for me, a better option.

I've been happy since because we are the gatekeepers. So we do the stenting and the operations ourselves, and we do hybrid operations all the time, and we have much more different areas to operate in.

So as the surgeons have the purpose of returning people into the society to do things that they're supposed to do, the heart has the purpose to supply the rest of the body with blood so that blood can do the things that we want to do. So for me, it was a more appealing part of medicine.

Am I biased? Obviously, we are all biased in some way. We try to and tend to think that we are not biased. Medistim doesn't pay me enough to be biased. The University Hospital of Helsinki has paid my salary for 25 years or so. Take out a couple of visits abroad. I had five interesting years.

As you can see, I started 17 actually as a treasurer of the society, and you remember there were some incidents like COVID, so we had to reinvent the economics of the European society. During that time, we also bypassed our American friends. Our journal is the leading journal in the world, and we created a program of guidelines and webinars and stuff like that. So it was also very agile working in the society.

Kari said that I am the president of the Finnish Vascular Society. That's not true. I'm the president of the Society of Surgery because I believe in collaboration. We do a lot of operations with urology, GI surgeons, also cardiac surgeons together. So I'm running the surgical society. We had a meeting last week in Lapland, and it's very good discussions, to discuss with different specialties.

I try to keep my presentation in time and on a very basic level. I'm focusing on Finland, you know, where the happiest country in the world. This is our hospital centralized system in Helsinki where by the sea we actually now have a new restaurant that has a sea view, very beautiful towards the west. So we have a nice sunny day afternoon.

We divide our country into five regions. It's 5.5 million. So a bit like Norway. The people live in the south and reindeer in the north, and this area that we cover with this university hospital is about 1.7 million primary catchment area. Our secondary catchment area is 2.3, and the Territory catchment area is 5.5 million people, and some functions are centralized to Helsinki, obviously the patients from abroad are quite rare.

They used to be more common when the Americans were working still in Russia, and they wanted their personnel to be operated in Helsinki because it was much cheaper than operating in Mount Sinai.

We do about 5000 and so annual operations, so both endovascular and open arterial. So that's about, well, volume for 1.72 million persons annually.

This slide actually shows the topic of today. So since 1971, we've been gathering and vascular and surgical procedures you can do. You can see that we do more endovascular procedures than we do open surgical procedures. The main reason for this is that redo procedures for the same patients are more common in the endovascular area than in open surgery.

Of course, we do a redo in open surgery as well, but you can see that since the last ten or so 15 years, the number of open surgery has been quite stable. So it's not going down, and the endovascular procedures are also stable ish 2000, 2500. So that peak in 21 is still there, but it came down a bit in 22.

This we have had since 2003, these hybrid theaters where you can do surgery and angiography for the same patient at the same time simultaneously, and it has a long learning curve. So if the cardiac surgeons are now starting the hybrid operations, it will take you like ten years before you reach a plateau.

Today you can see the usage we have for hybrid operation. The theater is one for neurosurgeons, three for vascular surgeons, where the cardiac cardiologist actually put every now and then a TAVI, an aortic valve. A very good procedure as well.

Well, that's the distribution of the operations, which is quite stable. But this is interesting. This was for my presentation last week, but I took it here because this is the main theater, which is soft tissue surgery without orthopedics and trauma. Mainly we have some urology, but GI surgery, cardiac surgery, and vascular surgery are the three big ones.

And these are the hours last year spent in the O.R. And you see that we are slower than the cardiac surgeon just because we spend more hours, and the GI surgeons are the least. But you see, we have outnumbered also in the number of operations, the cardiac surgical procedures today.

So only a couple of slides about TTFM, the real difference between TTFM and ultrasound flow, you can measure the flow with ultrasound as well. Also intraoperatively. During the 20 or so years, there's been a couple of tries in the market with very high-frequency ultrasound probes measuring that the flow.

But the difference is that whereas this looks at the actual movement within the vessel, like this, it doesn't assume that the thing in this case, the vessel is round, whereas ultrasound does, which leads to a problem because the mistake in the measurement is also exponential, whereas it's linear in the TTFM.

So that's why TTFM is a better measure of flow during surgery than traditional ultrasound. It's simple mathematics.

Early on, my former boss, Anders Albâck, did his thesis in 2000 about the bypass grafts and their patency. So this means that how long did the grafts stay open, and he could show in his thesis in a very small group that when the flow was above a 90, the probability of staying open was much higher than when the flow was below 90.

So this is early work with a TTFM device. I don't know if it was Transonic or Medistim or even I didn't know the name Medistim for a couple of years ago, so I'm not attached that much. And this is another study from his thesis where he could show that the flow quartile also predicted graft the need for a redo PTA or redo bypass redo correction so graft stenosis.

There are no exact, or one of the problems with TTFM or any flow measurement is that there are no exact cutoff values. This is one of the early series of more than 8000 measurements. And we kind of had the femoral popliteal femoral crural so meaning that you do a bypass from groin to the popliteal region, groin to the smaller ones, which are about a bit bigger actually than the coronary arteries.

But then when you go to the foot foot to save a leg, then they are the size of the coronary artery. But the bypass is much longer, which means that there is a lot more problems also in the graft. So we need to be certain that the grafts are okay when we're leaving the OR.

And here we can see the assumed cutoff limits were from where and our experience we published. I think this is the only table published from the recommendations of the flow, what they should be within the peripheral vascular field and is what we see in practice what the flow should be about.

Our friends well our friends are Alik and Matthew Minard but the Americans got a lot of money I think it was 40 million from the Obama administration to try to find a solution to a question that had been addressed previously with randomized studies, but they were not very good

There is a vessel I and vessel II trial which are which are the UK based but there is a problem in recruitment and also problem because the stenosis or occlusion actually in our case it can be anywhere from from the descending thoracic aorta to the maleolar level. So and there's a lot of occlusion.

So the variability of treatment methods is very big. But the beauty in this BEST-CLI was that when Ali came for the first time to Helsinki to present it, they tried to find this equipoise. So, that the surgeon and the angio radiologist and the endovascular surgeons, they agreed that this patient can be treated with any of the methods, either intraluminally and endovascularly or with the bypass surgery.

And we were the first and only site in Finland and outside US actually to recruit in this one. Uh, there was some other center one, one other center in Italy, but otherwise this is a very American study.

And what they did was that they chose that this is one cohort, there's another cohort as well. But this is the main finding. So they had 1400 or so patients and then they randomized whether to do open or bypass. And the treating physicians had to agree that this can be done in any of the methods.

And this is a well-designed performed study. The main finding is in the upper left hand corner that that the event rate of the major reintervention above angle amputation or of course death which was not different that's you can see people do die if they have atherosclerosis they have about in claudication about 20% chance of dying in five years.

So the treatment with statins and cholesterol treatment and aspirin. That's very important. But they don't die because of their leg. But they do. They get complications like amputations. And so and the most clearly it was seen, as I said, in the re intervention.

So this is the first time to show in a randomized fashion that bypass surgery in the lower limb is more durable than endovascular treatment in patients where you can do choose either and this is in numbers, you can see that the number of reinterventions in the bypass surgical group is in If you look this is around two or three years, you see that there's 100 reinterventions.

So you can count the numbers, the economical figures from here as well. They are about as costly because the devices are more expensive in the endovascular group, but the surgical treatment and the postoperative treatment, this is more costly in the open surgical group.

So our routine just highlighted the routine here. So we do for every patient we do a bypass on we do a TTFM, we do selective imaging either with an Angio or with an ultrasound. I nowadays do always proximal and distal ultrasound because because it is there, because we have it all the time.

Somebody asked if there a competition on the market, not on the TTFM, but ultrasound can do with almost any device. The beauty in the Medistim device is that it's very high flow and the probe is very good. So you can see very clearly the small details. But ultrasound does exist in all the GE, Philips, Siemens, Samsung has the best image quality at the moment in the monitors. So that does exist. But TTFM does not.

So this is what we do. This is just an example, a groin procedure with a bifurcated venous bypass. There was an infection in the groin. We had to take out the artery and replace that one. And in the end, we measured the flow in the superficial femoral artery, which is the one that goes down, you could see a reasonably good flow pulsatility index point eight.

It's a bit high, but in the deep femoral, which takes the blood into the thigh area, there was almost no flow. So we had to do some corrective measures and then it was corrected. And prior to dilatation, we do that with heroin actually it’s called Papavarine. It's a heroin surrogate. It makes a maximal dilatation of the vessels. We could see that the flow went up to 270 ml per minute pulsatility index down to one. And then we could be happy with a correction.

So this is how a threatened limb looks like. This is just a case with a patient who had a FemPop previously. And it occluded, there was a very experienced surgeon, fairly good quality vein they did a completion angio but still the bypass was occluded one day. In the primary operation they did an angio but here you can if you look at this region up here, you can see a quite nice proximal area. Then we checked the, because there's an end to an anastomosis in the graft for example, we checked that. We checked also with ultrasound the distal anastomosis. And what we finally found was in the proximal anastomosis, there was a clamp damage. You can see that here. Here's the dissection as John was also showing. And here you can see the first image. But when you take a new image and you turn the a patient a bit around or the sea arm a bit around, you see that it should have been seen already in the first part. And that was then corrected and the patient did fine.

I told you that the beauty in the probe is that it's readily available and you can either look before the you do the bypass or whatever. This is similar to what John showed that you don't want to do the bypass here, but you want to do it here. So the anastomosis, so that's that's fairly similar in our case. And then you can check and I think these images are quite interesting because you can see the flow and you can see in the B-mode without the colors and without the other stuff that blood actually flows quite slowly in the arteries, even in the aorta, which you would intuitively I at least thought originally that it goes very fast because if you open an aorta it comes quite fast out. But there is a resistance all the time and here you can see with with a good quality ultrasound you can see small details in the flow pattern and is what is most important. I will maybe show in a later picture what you can see is the proximal end here. So the Intima media that John was talking about, you can actually see the Intima media. And that's a that's a difference. Most of the the ultrasound probes, this is rubbish. This doesn't tell you much. It looks nice in the picture, but it very doesn't tell you much. So it's actually the B-mode image that we look at. Of course, we sometimes check the flow and so forth, but that is in all the I mean, in all the machines, it has to be adjusted quite a lot to get the colors right and so forth is very, very valuable when you do venous imaging or if you do graft control and stuff like that with ultrasound. But so far it's not yet good for intraoperative use. It will be in the future, I'm sure.

Ross Naylor used to be like for 30 years the man on both sides of the Atlantic to talk about carotid surgery. He was my opponent in 2011 in my thesis. And when he went on pension, he took one more task to do with the new guy. The updated guidelines there were the original ones. By 2017, the latest ones, and now he updated them quite recently. And this is the European Society that is the opinion leader globally at the moment. And 77 recommendation, which is a new one, is now recommending that there should be a completion control. So virtually now all the guidelines say that when you're finishing the surgery you should do a completion control. And Christoph Knappich who is the only quote here is a friend of ours in Munich, and Christoph has actually the exactly the same protocol in the carotid field as we've been doing in Helsinki.

So carotid surgery. Why do we do carotid surgery? Because we don't want to get the strokes and strokes is bad. So that's why we do carotid surgery. Why do we want to perform good quality completion control? Because we don't want to cause the strokes. There's a 0.3 to 3% risk to 6% allowed risk in the very risky patients of stroke within 30 days of the surgery. So we want to leave out the operation room. We do actually patients in local anesthesia here. So we see that they don't get any problems during the surgery. But then when we leave that we actually what we see on there is only the beautiful surface that we want to see a bit deeper. And that's why we perform ultrasound at the end. Since five years, we've been doing a routine ultrasound at the end of every carotid operation. There are some problems still, the nurse has to work the machine and so forth. But actually they are doing that quite well.

So this device in our hands works quite routinely and well. This is just to show you what it means when you do an ultrasound before you clamp the carotid arteries, you want to put the clamp there. This is called a floating thrombus. It moves like that.

And if it loosens up from there, it goes up north as they say, and you get the stroke. And that's what it looks like when you open the artery. And you can see that it's quite loosely attached here. So you don't want to manipulate it. So it's important to know that it is there. Then you see a lot of damages. If you look at the scale here, just 15 millimeter here, seven here. So everything here is one millimeter and this is a clamp damage. But we didn't do anything to it because it's only one millimeter or so. It's not flow limiting. But what we do do is that we don't put protamine we put heparin, which makes the blood flow. It's like juice so it doesn't clot. And at the end of the operation because we don't want them to bleed, we put protamine but in these cases where you see something, you don't put protamine and then you maybe put a bit more medication postoperatively in order to prevent the postoperative thrombosis and stroke here. So that's the value there. And then you want to see the distal anastomosis, that stent that there's no dissection, no flow remitting things. And once our surgeons have been starting to do this routinely, everybody has changed something in the practice. Me too. I abandoned some techniques that I've learned in the UK when I was practicing there, they even published some techniques that I only found that are not good because of of doing these routine ultrasounds.

Once the surgery becomes more complex, obviously when you're moving in your career you do more and more complex surgery. I today am responsible for oncovascular and aortic surgery, which means that we take out tumors that grow into vessels and we do a lot of different bypasses. So these operations can take either a short time or 12, 14 hours or so. And during that surgery, you need to be sure that the organs get the blood. So you want to measure flow during this surgery, for example, in this benign tumor of a 30 year old guy of leiomyosarcoma of the iliac vein at the end of the operation, we wanted to see that the flow is good. Here you see the inferior vena cava, which looks like the flow in the heart. You saw these curves that looks like a low resistant flows. That's the vena cave. But the flow is a bit different. It's three liters per minute. And this goes down to one leg, 1.9 liters. I mean, it was a big guy. That's a big flow. But when you're leaving the Operation Theater, you need to be certain that there's a good flow and the patient is not ischemic. In the awakening in this oncovascular stuff, we do hepatic surgery or pancreatic surgery together with our pancreatic surgeons. How we solve some of the reconstructions both in in the transplant region and in these pancreatic operations. We do these spirals and obviously you want to do an ultrasound and check that everything is good because you because after this when they do a Whipple when they take out the head of the pancreas, they do a lot of anastomosis for the bile and for the intestine and so forth. So everything is covered. So if you need to go back in there and you open the abdomen again, if there's no adhesions in the beginning but there's a lot of other stuff that they've done. So you have to be certain before you allow the next guy to do the next anastomosis on that, that everything is okay. So that's why during the operation it's vital to check it also in some cases like this guy in trauma like in this guy who who fell on a construction site and there's an iron bar through his axilla here. Not a nice thing, but actually what we were able to do because we measured both the flow and the and checked with ultrasound was to to put a syringe on that one and then just pull it out and close the wound. But we would not in any other way. Well we could have performed an angiography or something but there was no damage to anything, just taking out the iron bar.

So I do believe in science. I have one more further disclosure to make in the environment. Well, I've been growing where I've been doing my peripheral vascular surgery. We've been doing all the time TTFM, because it was taken into practice in the eighties and nineties before my time. So it's like a parachute to me. But I do believe in science. I also take this classical study from the British British Medical Journal, where 23 of the 92 people who were asked for the study agreed to jump off an airplane either with or without the parachute. And you could actually see no difference in major injury or death. So jumping off the airplane without a parachute is totally safe. They had 92 screened, 69 excluded. Finally, 23 were randomized because some of the people thought that it's not a good idea. So 12 jumped with a parachute and 11 with a control. Three of them could not be contacted, but they were the ones with the parachute and they had a 30 day follow up. And so so we could conclude that jumping off an airplane with or without a parachute is totally similar. It's like operating with or without a TTFM. But there has to be some conditions to that. Thank you very much.