Randolph Martin, MD speaks with Anelechi Anyanwu, MD, and Enoch Akowuah, MD about the UK Minimitral Trial. The trial was conducted to compare minimally invasive right thoracotomy to conventional sternotomy for MV repair focusing on outcomes and important patient issues such as quality of life and physical activities.
For the primary outcome - how quickly patients recover from surgery at 12 weeks - there was no difference between the two groups. However when looking at secondary outcomes, the mini patients recovered quicker at 6 weeks – including physical activity and sleep. Efficacy was the same for both groups at 12 weeks and 1 year. Freedom from mitral regurgitation was also the same in both groups.
About the AATS Mitral Conclave: David H. Adams, MD, and Anelechi C. Anyanwu, MD, serve as the Program Directors of the AATS Mitral Conclave – a meeting that Dr. Adams created with the American Association for Thoracic Surgery in 2011. The biennial meeting brings the world’s leading experts together to examine all aspects of mitral valve disease, associated conditions, and treatment. The meeting featured more than 350 presentations, 40 focused breakout or lunch sessions, combined with four main plenary sessions – with over 900 attendees from 52 countries.
Enoch Akowuah, MD Academic Consultant Cardiothoracic Surgeon Newcastle University and South Tees NHS Foundation Trust Hi, I'm Doctor Randy Martin. We're here at the 2023 A TS Metro Con Coy and I to be joined by Enoch. Oka. Good, good to see you and Anie Anan. Good to see you. We're gonna talk about the UK Mimi. I know that you guys just literally got off the podium right behind you talking about it. But it, it's really gotten a lot of attention in the medical world. You gave a talk at the AC C audit and you've done stuff here. So tell me just for the audience that's not familiar with it. What was the UK mini mindful? So the best approach to repair my is something that we've been debating in the surgical community for years. And, and that was the main reason to do the trial because I think there's a lot of uncertainty about what the best approach is. Patients tend to come to us wanting a minimally invasive approach because they have a perception that they will get better quicker after surgery. But the evidence to support that and particularly the evidence around the efficacy of how well it works. And then the safety compared to standard therapy has never really been tested in a randomized control trial. So that's really the reason for the trial is to work out whether one approach might be better than the other. And particularly focusing on the things that patients want to look at in order to help them make a choice between the two techniques. So the outcomes of the trial are very much driven by what patients want to see from this. You talk about quality of life post operative. Is that right? Yeah, I mean, to some extent, but I think physical function was the only thing is how quickly can you get it exactly, get back to doing what I normally do. That many were all sorts of many. The mini was all mini thoro it didn't include robotics or other. It did not, it was just mini thoracotomy operations. Well, the findings were for the primary outcome which was essentially how quickly you recover from surgery. At 12 weeks, there were no, there was no difference between the two groups. So that was interesting and suggest that although the destination is going to be the same. So then the secondary outcomes are. So what's the journey like if you like? So what about the other things that patients? So we found that the mini patients recovered quicker at six weeks. So they were already benefiting from the operating and doing more physical. Exactly. Their physical activity was more and their sleep was more, which is an interesting outcome that I've never really looked at, but one that patients kept on telling us was really important to them. And then of course, the key thing is that efficacy. So could we repair as many valves and could we repair them as well? And that was the same in the two arms as well? You're talking about durability, you talk about Mr at a certain. Yes. So we measured Mr early and late after surgery. So up to 12 weeks and then up to one year and at both times, they were the same in the two groups. Interesting, Arnie, what are your thoughts we discussed? I think it's an amazing study. It's very difficult to do and realize that trials in surgery or one of the difficulties with surgery is the treating us. I outlined it. So a patient who perceives they had a less invasive treatment will always perceive a better outcome almost always. And there's a placebo effect with any therapy that's perceived to be better. And I think that clouds the analysis, but in terms of the pains that are very objective, for example, freedom of micro regurgitation, it was the same in both groups, the patient and you had a blinded call up. Correct. Yes. So the people reading the echos didn't know what to show. So that's very objective and they found no difference which, which I think is very interesting. But what I also found interesting is we've always thought you recover quicker if you have smaller incisions. But that seems not to be the case and you can recover as quick. No, no, I think that's right. I mean, I think the first thing is around the inability to blind patients. That's a fact that's a surgical trial. I guess one thing I would say is that if there was going to be bias, then it, it's usually in favor of the new intervention. So the fact that the primary outcome was the same, I think is important because it tells us that if there is bias, actually, it didn't affect the primary outcome because they were the same, you'd expect the media maybe to have reported much improved outcomes. So that's, that's, that's good to know. I mean, as you say, we did as much as we can to reduce that bias. So we had a blinded observer doing the sf 36 we use the solar which is just an objective measure. And of course, we use the Echo Core lab. So as much as we could, we tried. But of course, these are the constraints of doing a trial like this patients. It was my patience and talking to them. All they care about is the size of the scar and not, not doing. You're not gonna do anything by stirring up A I mean, that's basically the patients don't really understand the durability or the outcome. So I'm not surprised that you, you know, at six weeks, you had a little faster pop back. It doesn't surprise me at all. But durability you're gonna follow these patients. Yes. So five years. So all these patients, we follow up for five years. So at some point, we hope to present on the five year data. I think you're absolutely right. The question around the is very important. Also the techniques were different. So we didn't mandate the techniques, but we saw clearly that in the Synot arm, more patients were getting leaflet reception. And in the mini arm, more patients were getting operations, valves repaired using loops or cord or loop techniques. So I think it'd be really critical to see that the long term outcome of the two arms were, you know, all patients had a ring, every patient had a ring in the trial. But that's one thing that concerns me about a lot of these studies that the patients are not getting the same. No, no, whatever we think. So it's like if you did a trial in cardiology and advise people to have failure therapy as opposed to say nothing but that heart failure therapy for some could be an ace inhibitor or it could be AAA beta blocker, it could be anything, it becomes harder to know what actually is being compared with what. And it could be that five years from now, if you found the difference and one group is superior to the other, it might not be the incision but it might be because in one group, you use more cortex cords or you use more resections or you use more edge to edge and so on. So that's the difficulty of having surgical trials where the surgeons can. But I mean, what I would argue is the balance. So except everything you say. But the thing is when you do these trials, you want them to be as pragmatic so that they can. So I think there's a, there's a limit to how you, you can't force a surgeon to do what they are. Not just because it would be to the detriment of the PA was the same borrowers. Any mac patients. No, no, it was, it was an exclusion because the M DC essentially had to decide that the patient would be suitable for both. But it was interesting when we look at the data, there were not many patients with, with d what we call, there's a team and there were no concomitant procedure. There weren't any or anything, no mazes. About a third of patients in a f had a maze procedure. So mazes were allowed. Tricuspid repair was allowed and of PFO so anything that could be done through the minimization incidence of a fib one year out and stuff like that after a maze? No. So the numbers are small and I, I don't think they're meaningful enough to make a significant point. So what do you think this? And, and I heard your comments and it's true that the non robotic many surgery is much more accepted in the UK than it is here. Basically. I'm not saying it's better. I'm just saying it's more accepted. We're here. It's robotic or, or, yeah, we seem to do very few robotics to robotic Marshalls in the UK that the technology hasn't penetrated as much. It's been really interesting at this meeting. I've seen a lot, I think the other issue and of which you brought up in your presentation you haven't talked about yet is the cost effectiveness because you, I mean, I'll let you talk on that, but the robot is probably not as cost effective as doing am? Yes, that's, there's no doubt about that. You found it more cost effective than Yeah. No, I think that's, I mean that cost effective than snoy over, over one year within the NHS. So those caveats are important because it's quite difficult to translate health, economic data cross. That's largely because you saved the day of hospitals. So it length of stay is reductions in readmissions. So the days allowed hospital and improved quality of life because of course, quality of life goes into that. So all three elements contributed a better um cost effectiveness. What are your thoughts sitting in, in New York City at a major repair center? I was surprised at the results because I would have thought that in an expert based trial where patients are presumably getting the best of both. I actually would have thought that we would have been able to show that the less invasive patients recover faster after 12 weeks. So I, I was surprised it didn't meet the primary outcome. I mean, I thought because they run in circles around there. People like six weeks and three months, even the three months I know for people my patient, so three months they're not rock and roll. But, but that's why John Hunter who was a famous British UK surgeon said that you have to do the experiment. Exactly. Because when you do the experiment, the results may be different. Iii I could not agree more. I also expected that. So, but I'm, it's, it's great to be do a track because actually we've, we've heard people talk about individual experiences and kind of give us the impression that as you say, patients who have mini invasive just recovered with day three and there. But the reality is obviously what we see in this call you at 30%. Correct. Correct. Yeah, men do worse with post operative way with auto and, and the other is, yes. Yes. That's true. The other interesting thing because a comment, someone made to me while I was listening to your presentation was your my one year. It was something like 8% had more than miles, it 92% of the year. And he said, oh, that's 8%. That, that's not what we see and I said, but how do you know? I said you haven't sent all your hair to a call one year. But if you do, you may be surprised what you find. I think your data will answer a lot of questions other than that of just many because having call up data or after surgery for one year. Yeah, there is very little data out there on that quality for that duration. Well, listen, congratulations on your study and thank you so much for joining us on it. Thank you. Thank you very interesting data and be sure to follow it. Thanks.